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Meta-Analysis
. 2019 Jan 18;1(1):CD011825.
doi: 10.1002/14651858.CD011825.pub2.

Adverse events in people taking macrolide antibiotics versus placebo for any indication

Malene Plejdrup Hansen  1 , Anna M Scott, Amanda McCullough, Sarah Thorning, Jeffrey K Aronson, Elaine M Beller, Paul P Glasziou, Tammy C Hoffmann, Justin Clark, Chris B Del Mar
Affiliations
Meta-Analysis

Adverse events in people taking macrolide antibiotics versus placebo for any indication

Malene Plejdrup Hansen et al. Cochrane Database Syst Rev. .

Abstract

Background: Macrolide antibiotics (macrolides) are among the most commonly prescribed antibiotics worldwide and are used for a wide range of infections. However, macrolides also expose people to the risk of adverse events. The current understanding of adverse events is mostly derived from observational studies, which are subject to bias because it is hard to distinguish events caused by antibiotics from events caused by the diseases being treated. Because adverse events are treatment-specific, rather than disease-specific, it is possible to increase the number of adverse events available for analysis by combining randomised controlled trials (RCTs) of the same treatment across different diseases.

Objectives: To quantify the incidences of reported adverse events in people taking macrolide antibiotics compared to placebo for any indication.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which includes the Cochrane Acute Respiratory Infections Group Specialised Register (2018, Issue 4); MEDLINE (Ovid, from 1946 to 8 May 2018); Embase (from 2010 to 8 May 2018); CINAHL (from 1981 to 8 May 2018); LILACS (from 1982 to 8 May 2018); and Web of Science (from 1955 to 8 May 2018). We searched clinical trial registries for current and completed trials (9 May 2018) and checked the reference lists of included studies and of previous Cochrane Reviews on macrolides.

Selection criteria: We included RCTs that compared a macrolide antibiotic to placebo for any indication. We included trials using any of the four most commonly used macrolide antibiotics: azithromycin, clarithromycin, erythromycin, or roxithromycin. Macrolides could be administered by any route. Concomitant medications were permitted provided they were equally available to both treatment and comparison groups.

Data collection and analysis: Two review authors independently extracted and collected data. We assessed the risk of bias of all included studies and the quality of evidence for each outcome of interest. We analysed specific adverse events, deaths, and subsequent carriage of macrolide-resistant bacteria separately. The study participant was the unit of analysis for each adverse event. Any specific adverse events that occurred in 5% or more of any group were reported. We undertook a meta-analysis when three or more included studies reported a specific adverse event.

Main results: We included 183 studies with a total of 252,886 participants (range 40 to 190,238). The indications for macrolide antibiotics varied greatly, with most studies using macrolides for the treatment or prevention of either acute respiratory tract infections, cardiovascular diseases, chronic respiratory diseases, gastrointestinal conditions, or urogynaecological problems. Most trials were conducted in secondary care settings. Azithromycin and erythromycin were more commonly studied than clarithromycin and roxithromycin.Most studies (89%) reported some adverse events or at least stated that no adverse events were observed.Gastrointestinal adverse events were the most commonly reported type of adverse event. Compared to placebo, macrolides caused more diarrhoea (odds ratio (OR) 1.70, 95% confidence interval (CI) 1.34 to 2.16; low-quality evidence); more abdominal pain (OR 1.66, 95% CI 1.22 to 2.26; low-quality evidence); and more nausea (OR 1.61, 95% CI 1.37 to 1.90; moderate-quality evidence). Vomiting (OR 1.27, 95% CI 1.04 to 1.56; moderate-quality evidence) and gastrointestinal disorders not otherwise specified (NOS) (OR 2.16, 95% CI 1.56 to 3.00; moderate-quality evidence) were also reported more often in participants taking macrolides compared to placebo.The number of additional people (absolute difference in risk) who experienced adverse events from macrolides was: gastrointestinal disorders NOS 85/1000; diarrhoea 72/1000; abdominal pain 62/1000; nausea 47/1000; and vomiting 23/1000.The number needed to treat for an additional harmful outcome (NNTH) ranged from 12 (95% CI 8 to 23) for gastrointestinal disorders NOS to 17 (9 to 47) for abdominal pain; 19 (12 to 33) for diarrhoea; 19 (13 to 30) for nausea; and 45 (22 to 295) for vomiting.There was no clear consistent difference in gastrointestinal adverse events between different types of macrolides or route of administration.Taste disturbances were reported more often by participants taking macrolide antibiotics, although there were wide confidence intervals and moderate heterogeneity (OR 4.95, 95% CI 1.64 to 14.93; I² = 46%; low-quality evidence).Compared with participants taking placebo, those taking macrolides experienced hearing loss more often, however only four studies reported this outcome (OR 1.30, 95% CI 1.00 to 1.70; I² = 0%; low-quality evidence).We did not find any evidence that macrolides caused more cardiac disorders (OR 0.87, 95% CI 0.54 to 1.40; very low-quality evidence); hepatobiliary disorders (OR 1.04, 95% CI 0.27 to 4.09; very low-quality evidence); or changes in liver enzymes (OR 1.56, 95% CI 0.73 to 3.37; very low-quality evidence) compared to placebo.We did not find any evidence that appetite loss, dizziness, headache, respiratory symptoms, blood infections, skin and soft tissue infections, itching, or rashes were reported more often by participants treated with macrolides compared to placebo.Macrolides caused less cough (OR 0.57, 95% CI 0.40 to 0.80; moderate-quality evidence) and fewer respiratory tract infections (OR 0.70, 95% CI 0.62 to 0.80; moderate-quality evidence) compared to placebo, probably because these are not adverse events, but rather characteristics of the indications for the antibiotics. Less fever (OR 0.73, 95% 0.54 to 1.00; moderate-quality evidence) was also reported by participants taking macrolides compared to placebo, although these findings were non-significant.There was no increase in mortality in participants taking macrolides compared with placebo (OR 0.96, 95% 0.87 to 1.06; I² = 11%; low-quality evidence).Only 24 studies (13%) provided useful data on macrolide-resistant bacteria. Macrolide-resistant bacteria were more commonly identified among participants immediately after exposure to the antibiotic. However, differences in resistance thereafter were inconsistent.Pharmaceutical companies supplied the trial medication or funding, or both, for 91 trials.

Authors' conclusions: The macrolides as a group clearly increased rates of gastrointestinal adverse events. Most trials made at least some statement about adverse events, such as "none were observed". However, few trials clearly listed adverse events as outcomes, reported on the methods used for eliciting adverse events, or even detailed the numbers of people who experienced adverse events in both the intervention and placebo group. This was especially true for the adverse event of bacterial resistance.

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Conflict of interest statement

Malene Plejdrup Hansen: senior research fellow at the Research Unit for General Practice in Aalborg funded by the Research Foundation of General Practice in Denmark. From 2014 to 2016 she was a postdoctoral fellow at the Centre for Research Excellence in Minimising Antibiotic Resistance from Acute Respiratory Infections (CREMARA) funded by the National Health and Medical Research Council (NHMRC), Australia (1044904).

Anna M Scott: senior research fellow at the Centre for Research Excellence in Minimising Antibiotic Resistance from Acute Respiratory Infections (CREMARA) funded by the National Health and Medical Research Council (NHMRC), Australia (1044904).

Amanda McCullough: postdoctoral fellow at the Centre for Research Excellence in Minimising Antibiotic Resistance from Acute Respiratory Infections (CREMARA) funded by the National Health and Medical Research Council (NHMRC), Australia (1044904).

Sarah Thorning: none known.

Jeffrey K Aronson: is a President Emeritus of the British Pharmacological Society and a member of the Advisory Board of the British National Formulary; was until recently a member of a Technology Appraisal Committee of the UK’s National Institute for Health and Care Excellence (NICE); and is editor of textbooks on adverse drug reactions, including Meyler’s Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions. He has published in peer‐reviewed journals on different aspects of adverse drug reactions.

Elaine M Beller: co‐investigator on the National Health and Medical Research Council (NHMRC)‐funded Centre for Research Excellence grant on Antibiotic Resistance.

Paul P Glasziou: co‐investigator on the National Health and Medical Research Council (NHMRC)‐funded Centre for Research Excellence grant on Antibiotic Resistance.

Tammy C Hoffmann: co‐investigator on the National Health and Medical Research Council (NHMRC)‐funded Centre for Research Excellence grant on Antibiotic Resistance.

Justin Clark: Information Specialist of the Cochrane Acute Respiratory Infections Group and partly funded by the Centre for Research Excellence in Minimising Antibiotic Resistance from Acute Respiratory Infections (CREMARA) funded by the National Health and Medical Research Council (NHMRC), Australia (1044904).

Chris B Del Mar: Co‐ordinating Editor of the Cochrane Acute Respiratory Infections Group and chief investigator at the Centre for Research Excellence in Minimising Antibiotic Resistance from Acute Respiratory Infections (CREMARA), both funded by the National Health and Medical Research Council (NHMRC), Australia. He has received royalties from BMJ Books and Elsevier for activities unrelated to this submitted work.

Figures

1
1
PRISMA study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD011825

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    1. Currier JS, Williams PL, Koletar SL, Cohn SE, Murphy RL, Heald AE, et al. Discontinuation of Mycobacterium avium complex prophylaxis in patients with antiretroviral therapy‐induced increases in CD4+ cell count. A randomized, double‐blind, placebo‐controlled trial. Annals of Internal Medicine 2000;133(7):493‐503. - PubMed
Curry 2004 {published data only}
    1. Curry JI, Lander AD, Stringer MD. A multicenter, randomized, double‐blind, placebo‐controlled trial of the prokinetic agent erythromycin in the postoperative recovery of infants with gastroschisis. Journal of Pediatric Surgery 2004;39(4):565‐9. - PubMed
Czarnetzki 2015 {published data only}
    1. Czarnetzki C, Elia N, Frossard JL, Giostra E, Spahr L, Waeber JL, et al. Erythromycin for gastric emptying in patients undergoing general anesthesia for emergency procedures. Swiss Medical Weekly 2014;144:S5. - PubMed
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    1. Ehsani Ardakani MJ, Zare E, Basiri M, Mohaghegh Shalmani H. Erythromycin decreases the time and improves the quality of EGD in patients with acute upper GI bleeding. Gastroenterology and Hepatology From Bed to Bench 2013;6(4):195‐201. - PMC - PubMed
El‐Sadr 2000 {published data only}
    1. El‐Sadr WM, Burman WJ, Grant LB, Matts JP, Hafner R, Crane L, et al. Discontinuation of prophylaxis for Mycobacterium avium complex disease in HIV‐infected patients who have a response to antiretroviral therapy. New England Journal of Medicine 2000;342(15):1085‐92. - PubMed
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    1. Eschenbach DA, Nugent RP, Rao AV, Cotch MF, Gibbs RS, Lipscomb KA, et al. A randomized placebo‐controlled trial of erythromycin for the treatment of Ureaplasma urealyticum to prevent premature delivery. The Vaginal Infections and Prematurity Study Group. American Journal of Obstetrics and Gynecology 1991; Vol. 164, issue 3:734‐42. - PubMed
Fonseca‐Aten 2006 {published data only}
    1. Fonseca‐Aten M, Okada PJ, Bowlware KL, Chavez‐Bueno S, Mejias A, Rios AM, et al. Effect of clarithromycin on cytokines and chemokines in children with an acute exacerbation of recurrent wheezing: a double‐blind, randomized, placebo‐controlled trial. Annals of Allergy, Asthma & Immunology 2006; Vol. 97, issue 4:457‐63. - PubMed
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Gharpure 2001 {published data only}
    1. Gharpure V, Meert KL, Sarnaik AP. Efficacy of erythromycin for postpyloric placement of feeding tubes in critically ill children: a randomized, double‐blind, placebo controlled study. Journal of Parenteral and Enteral Nutrition 2001; Vol. 25, issue 3:160‐5. - PubMed
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Glass 1999 {published data only}
    1. Clark SM. A double blind parallel group, clinical evaluation of the efficacy and safety of isotretinoin (0.05%) gel, erythromycin (2%) gel, a gel containing isotretinoin (0.05%) and erythromycin (2%) and a gel base (placebo) in the topical treatment of acne vulgaris. British Journal of Dermatology 1996;135(Suppl 47):28‐45.
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    1. Gokmen T, Oguz SS, Bozdag S, Erdeve O, Uras N, Dilmen U. A comparison of erythromycin and ursodeoxycholic acid in preventing liver function abnormalities during parenteral nutrition in VLBW infants. Early Human Development 2010;86:S83‐4.
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Gurfinkel 1999 {published data only}
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Hahn 2006 {published data only}
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Halperin 1999 {published data only}
    1. Halperin SA, Bortolussi R, Langley JM, Eastwood BJ, Serres G. A randomized, placebo‐controlled trial of erythromycin estolate chemoprophylaxis for household contacts of children with culture‐positive Bordetella pertussis infection. Pediatrics 1999;104(4):e42. - PubMed
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Heppner 2005 {published data only}
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Hodgson 2016 {published data only}
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Jespersen 2006 {published data only}
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    1. Johnston SL, Szigeti M, Cross M, Brightling C, Chaudhuri R, Harrison T, et al. A randomised, double‐blind, placebo‐controlled study to evaluate the efficacy of oral azithromycin as a supplement to standard care for adult patients with acute exacerbations of asthma (the AZALEA trial). www.ncbi.nlm.nih.gov/books/NBK390972/ (accessed prior to 6 January 2019). [DOI: 10.3310/eme03080] - DOI - PubMed
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Kaehler 2005 {published data only}
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Kalliafas 1996 {published data only}
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Karlsson 2009 {published data only}
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Kathariya 2014 {published data only}
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Kaul 2004 {published data only}
    1. Fonck K, Kaul R, Kimani J, Keli F, MacDonald KS, Ronald AR, et al. A randomised, placebo‐controlled trial of monthly azithromycin prophylaxis to prevent sexually transmitted infections and HIV‐1 in Kenyan sex workers: study design and baseline findings. International Journal of STD & AIDS 2001;11(12):804‐11. - PubMed
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Kenyon 2001b {published data only}
    1. Kenyon S, Brocklehurst P, Jones D, Marlow N, Salt A, Taylor D. MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes. BMC Pregnancy and Childbirth 2008;8:14. - PMC - PubMed
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Kim 2004 {published data only}
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King 1996 {published data only}
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Klebanoff 1995 {published data only}
    1. Klebanoff MA, Regan JA, Rao AV, Nugent RP, Blackwelder WC, Eschenbach DA, et al. Outcome of the vaginal infections and prematurity study: results of a clinical trial of erythromycin among pregnant women colonized with group B streptococci. American Journal of Obstetrics and Gynecology 1995;172(5):1540‐5. - PubMed
Kneyber 2008 {published data only}
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McCallum 2015 {published data only}
    1. Chang AB, Grimwood K, White AV, Maclennan C, Sloots TP, Sive A, et al. Randomized placebo‐controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol. Trials 2011;12:94. - PMC - PubMed
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McDonald 1985 {published data only}
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McGregor 1986 {published data only}
    1. McGregor JA, French JI, Reller LB, Todd JK, Makowski EL. Adjunctive erythromycin treatment for idiopathic preterm labor: results of a randomized, double‐blinded, placebo‐controlled trial. American Journal of Obstetrics and Gynecology 1986;154(1):98‐103. - PubMed
McGregor 1990 {published data only}
    1. McGregor JA, French JI, Richter R, Vuchetich M, Bachus V, Franco‐Buff A. Prospective, double‐blinded, randomized, placebo‐controlled trial of short‐course erythromycin (E) base in women at high risk for preterm birth. Society for Gynecologic Investigation. 1988.
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McGregor 1991 {published data only}
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Memis 2002 {published data only}
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Mercer 1992 {published data only}
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Moller 1990 {published data only}
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Neumann 2001 {published data only}
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Ng 2007 {published data only}
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O'Connor 2003 {published data only}
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Oei 2001 {published data only}
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Ozdemir 2011 {published data only}
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Pandhi 2014 {published data only}
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Pierce 1996 {published data only}
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    1. Burr SE, Camara B, Oluwalana C, Bojang E, Bottomley C, Bojang A. Does azithromycin given to women in labour decrease ocular bacterial infection in neonates? A double‐blind, randomized trial. BMC Infectious Diseases 2017;17(1):799. - PMC - PubMed
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Rozman 1984 {published data only}
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Saiman 2003 {published data only}
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Saiman 2010 {published data only}
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    1. Hogh A, Vammen S, Ostergaard L, Joensen JB, Henneberg EW, Lindholt JS. Intermittent roxithromycin for preventing progression of small abdominal aortic aneurysms: long‐term results of a small clinical trial. Vascular and Endovascular Surgery 2009;43(5):452‐6. - PubMed
    1. Vammen S, Lindholt JS, Ostergaard L, Fasting H, Henneberg EW. Randomized double‐blind controlled trial of roxithromycin for prevention of abdominal aortic aneurysm expansion. British Journal of Surgery 2001;88(8):1066‐72. - PubMed
    1. Vammen S, Lindholt JS, Ostergaard LJ, Fasting H, Henneberg EW. Reduction of the expansion rate of small abdominal aortic aneurysms with roxithromycin. Results from a randomized controlled trial [Hæmning af små abdominale aortaaneurismers ekspansion med roxithromycin. Resultater fra et randomiseret klinisk forsøg]. Ugeskrift for Laeger 2002;164:5916‐9. - PubMed
Van Delden 2012 {published data only}
    1. Köhler T, Perron GG, Buckling A, Delden C. Quorum sensing inhibition selects for virulence and cooperation in Pseudomonas aeruginosa. PLoS Pathogens 2010;6(5):e1000883. - PMC - PubMed
    1. Delden C, Kohler T, Brunner‐Ferber F, Francois B, Carlet J, Pechere JC. Azithromycin to prevent Pseudomonas aeruginosa ventilator‐associated pneumonia by inhibition of quorum sensing: a randomized controlled trial. Intensive Care Medicine 2012;38(7):1118‐25. - PubMed
Van den Broek 2009 {published data only}
    1. Broek NR, White SA, Goodall M, Ntonya C, Kayira E, Kafulafula G, et al. The APPLe study: a randomized, community‐based, placebo‐controlled trial of azithromycin for the prevention of preterm birth, with meta‐analysis. PLoS Medicine 2009;6(12):e1000191. - PMC - PubMed
Veskitkul 2017 {published data only}
    1. Veskitkul J, Wongkaewpothong P, Thaweethamchareon T, Ungkanont K, Visitsunthorn N, Pacharn P, et al. Recurrent acute rhinosinusitis prevention by azithromycin in children with nonallergic rhinitis. Journal of Allergy and Clinical Immunology: In Practice 2017;5(6):1632‐8. - PubMed
Videler 2011 {published data only}
    1. Videler WJ, Badia L, Harvey RJ, Gane S, Georgalas C, Meulen FW, et al. Lack of efficacy of long‐term, low‐dose azithromycin in chronic rhinosinusitis: a randomized controlled trial. Allergy 2011;66(11):1457‐68. - PubMed
Vos 2011 {published data only}
    1. Ruttens D, Verleden SE, Vandermeulen E, Bellon H, Vanaudenaerde BM, Somers J, et al. Prophylactic azithromycin therapy after lung transplantation: post hoc analysis of a randomized controlled trial. American Journal of Transplantation 2016;16(1):254‐61. - PubMed
    1. Vos R, Herck A, Vanaudenaerde BM, Verleden SE, Raemdonck DE, Frick A, et al. A prospective, randomized, placebo‐controlled trial of pre‐transplant and prompt post‐transplant treatment with azithromycin to improve early allograft function and outcome after lung transplantation (NCT01915082). Journal of Heart and Lung Transplantation 2018;37(4):S88.
    1. Vos R, Vanaudenaerde BM, Vleeschauwer SI, Schoonis A, Raemdonck DE, Dupont LJ, et al. Randomized, double‐blind, placebo‐controlled trial of azithromycin in lung transplantation: first interim results. Journal of Heart and Lung Transplantation 2009;28(2):S119.
    1. Vos R, Vanaudenaerde BM, Schoonis A, Raemdonck DE, Dupont LJ, Verleden GM. Azithromycin for bronchiolitis obliterans syndrome after lung transplantation. Journal of Heart and Lung Transplantation 2010;29(2):S94.
    1. Vos R, Vanaudenaerde BM, Verleden SE, Vleeschauwer SI, Willems‐Widyastuti A, Raemdonck DE, et al. A randomised controlled trial of azithromycin to prevent chronic rejection after lung transplantation. European Respiratory Journal 2011;37(1):164‐72. - PubMed
Wallwork 2006 {published data only}
    1. Wallwork B, Coman W, Mackay‐Sim A, Greiff L, Cervin A. A double‐blind, randomized, placebo‐controlled trial of macrolide in the treatment of chronic rhinosinusitis. Laryngoscope 2006;116(2):189‐93. - PubMed
Walsh 1998 {published data only}
    1. Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, et al. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD study group. Lancet 1998;351(9108):1005‐8. - PubMed
Wang 2012 {published data only}
    1. Wang Y, Zhang SL, Qu Y. Effect of clarithromycin on non‐eosinophilic refractory asthma [克拉霉素治疗非嗜酸粒细胞型难治性哮喘的疗效分析]. Journal of Clinical Pulmonary Medicine 2012;17:1948‐51.
Wiesli 2002 {published data only}
    1. Krayenbuehl PA, Wiesli P, Maly FE, Vetter W, Schulthess G. Progression of peripheral arterial occlusive disease is associated with Chlamydia pneumoniae seropositivity and can be inhibited by antibiotic treatment. Atherosclerosis 2005;179(1):103‐10. - PubMed
    1. Wiesli P, Czerwenka W, Meniconi A, Maly FE, Hoffmann U, Vetter W, et al. Roxithromycin treatment prevents progression of peripheral arterial occlusive disease in Chlamydia pneumoniae seropositive men: a randomized, double‐blind, placebo‐controlled trial. Circulation 2002;105(22):2646‐52. - PubMed
Wilson 1977 {published data only}
    1. Wilson SZ, Martin RR, Putman M. In vivo effects of josamycin, erythromycin, and placebo therapy on nasal carriage of Staphylococcus aureus. Antimicrobial Agents and Chemotherapy 1977;11(3):407‐10. - PMC - PubMed
Wilson 1979 {published data only}
    1. Wilson SZ, Martin RR, Putman M, Greenberg SB, Wallace RJ, Jemsek JG. Quantitative nasal cultures from carriers of Staphylococcus aureus: effects of oral therapy with erythromycin, rosamicin, and placebo. Antimicrobial Agents and Chemotherapy 1979;15(3):379‐83. - PMC - PubMed
Winkler 1988 {published data only}
    1. Winkler M, Baumann L, Ruckhaberle KE, Schiller EM. Erythromycin therapy for subclinical intrauterine infections in threatened preterm delivery ‐ a preliminary report. Journal of Perinatal Medicine 1988;16(3):253‐6. - PubMed
Wolter 2002 {published data only}
    1. Bowler SD, Masel PJ, Bell SC, Seeney SL, Wolter JM, McCormack JG. A prospective, randomised trial of long term azithromycin (AZM) versus placebo in cystic fibrosis: impact on clinical, laboratory and quality of life (QOL) outcomes. Fourteenth Annual North American Cystic Fibrosis Conference; 2000 Nov 9‐12; Baltimore (MD). Wiley‐Liss, Div John Wiley & Sons, 2000.
    1. Wolter J, Seeney S, Bell S, Bowler S, Masel P, McCormack J. Effect of long term treatment with azithromycin on disease parameters in cystic fibrosis: a randomised trial. Thorax 2002;57(3):212‐6. - PMC - PubMed
Wong 2012 {published data only}
    1. Jayaram L, Wong CA, Karalus N, Eaton T, Tong C, Hockey H, et al. Azithromycin decreases exacerbations in noncystic fibrosis bronchiectasis. Respirology 2012;17(Suppl 1):35.
    1. Wong C, Jayaram L, Karalus N, Eaton T, Tong C, Hockey H, et al. Azithromycin for prevention of exacerbations in non‐cystic fibrosis bronchiectasis (EMBRACE): a randomised, double‐blind, placebo‐controlled trial. Lancet 2012;380(9842):660‐7. - PubMed
    1. Wong CA, Jayaram L, Karalus N, Eaton T, Tong C, Hockey H, et al. Azithromycin decreases exacerbations in non‐cystic fibrosis bronchiectasis. American Journal of Respiratory and Critical Care Medicine 2012;185:A3657.
Yang 2013 {published data only}
    1. Yang SS, Pan XJ, Wang HG, Zhao GQ. A randomized, double‐blind and placebo‐controlled clinical trail of topical administration of 1% azithromycin eye drops for acute bacterial conjunctivitis. Zhonghua Shiyan Yanke Zazhi [Chinese Journal of Experimental Ophthalmology] 2013;31(2):182‐5.
Yeo 1993 {published data only}
    1. Yeo CJ, Barry MK, Sauter PK, Sostre S, Lillemoe KD, Pitt HA, et al. Erythromycin accelerates gastric emptying after pancreaticoduodenectomy: a prospective, randomized, placebo‐controlled trial. Annals of Surgery 1993;218(3):229‐38. - PMC - PubMed
Zahn 2003 {published data only}
    1. Burkhardt U, Zahn R, Hoffler U, Siegler KE, Frilling B, Weber M, et al. Antibody levels against Chlamydia pneumoniae and outcome of roxithromycin therapy in patients with acute myocardial infarction. Results from a sub‐study of the randomised Antibiotic Therapy in Acute Myocardial Infarction (ANTIBIO) trial [Antikörper gegen Chlamydia pnuemoniae und roxitromycin therapie bei patienten mit einem akuten myokardinfarkt ‐ ergebnisse einer substudie der randomisierten antibiotischen therapie beim akuten myokardinfarkt (ANTIBIO) studie]. Zeitschrift Fur Kardiologie 2004;93(9):671‐8. - PubMed
    1. Zahn R, Schneider S, Frilling B, Seidl K, Tebbe U, Weber M, et al. Antibiotic therapy after acute myocardial infarction: a prospective randomized study. Circulation 2003;107(9):1253‐9. - PubMed

References to studies excluded from this review

Aboud 2009 {published data only}
    1. Aboud S, Msamanga G, Read JS, Wang L, Mfalila C, Sharma U, et al. Effect of prenatal and perinatal antibiotics on maternal health in Malawi, Tanzania, and Zambia. International Journal of Gynecology & Obstetrics 2009;107(3):202‐7. - PMC - PubMed
Ballard 2007 {published data only}
    1. Ballard HO, Anstead MI, Shook LA. Azithromycin in the extremely low birth weight infant for the prevention of bronchopulmonary dysplasia: a pilot study. Respiratory Research 2007;8:41. - PMC - PubMed
Batieha 2002 {published data only}
    1. Batieha A, Yahia G, Mahafzeh T, Omari M, Momani A, Dabbas M. No advantage of treating acute respiratory tract infections with azithromycin in a placebo‐controlled study. Scandinavian Journal of Infectious Diseases 2002;34(4):243‐7. - PubMed
Doan 2017 {published data only}
    1. Doan T, Arzika AM, Ray KJ, Cotter SY, Kim J, Maliki R, et al. Gut microbial diversity in antibiotic‐naive children after systemic antibiotic exposure: a randomized controlled trial. Clinical Infectious Diseases 2017;64(9):1147‐53. - PMC - PubMed
Ferahbas 2004 {published data only}
    1. Ferahbas A, Utas S, Aykol D, Borlu M, Uksal U. Clinical evaluation of roxithromycin: a double‐blind, placebo‐controlled and crossover trial in patients with acne vulgaris. Journal of Dermatology 2004;31(1):6‐9. - PubMed
Figueiredo‐Mello 2018 {published data only}
    1. Figueiredo‐Mello C, Naucler P, Negra MD, Levin AS. Ceftriaxone versus ceftriaxone plus a macrolide for community‐acquired pneumonia in hospitalized patients with HIV/AIDS: a randomized controlled trial. Clinical Microbiology and Infection 2018;24(2):171‐4. - PubMed
Gong 2014 {published data only}
    1. Gong Y, Lu J, Ding X, Yu Y. Effect of adjunctive roxithromycin therapy on interleukin‐1β, transforming growth factor‐β1 and vascular endothelial growth factor in gingival crevicular fluid of cyclosporine A‐treated patients with gingival overgrowth. Journal of Periodontal Research 2014;49(4):448‐57. - PubMed
Makkar 2016 {published data only}
    1. Makkar J, Gauli B, Jain K, Jain D, Batra YK. Comparison of erythromycin versus metoclopramide for gastric feeding intolerance in patients with traumatic brain injury: a randomized double‐blind study. Saudi Journal of Anaesthesia 2016;10(3):308‐13. - PMC - PubMed
Nielsen 2016 {published data only}
    1. Nielsen HL, Kirk KF, Bodilsen J, Ejlertsen T, Nielsen H. Azithromycin vs. placebo for the clinical outcome in Campylobacter concisus diarrhoea in adults: a randomised, double‐blinded, placebo‐controlled clinical trial. PLOS ONE 2016;11(11):e0166395. - PMC - PubMed
Parker 2017 {published data only}
    1. Parker EP, Praharaj I, John J, Kaliappan SP, Kampmann B, Kang G, et al. Changes in the intestinal microbiota following the administration of azithromycin in a randomised placebo‐controlled trial among infants in south India. Scientific Reports 2017;7:9. - PMC - PubMed
Pazoki‐Toroudi 2010 {published data only}
    1. Pazoki‐Toroudi H, Nassiri‐Kashani M, Tabatabaie H, Ajami M, Habibey R, Shizarpour M, et al. Combination of azelaic acid 5% and erythromycin 2% in the treatment of acne vulgaris. Journal of Dermatological Treatment 2010;21(3):212‐6. - PubMed
Rasi 2008 {published data only}
    1. Rasi A, Tajziehchi L, Savabi‐Nasab S. Oral erythromycin is ineffective in the treatment of pityriasis rosea. Journal of Drugs in Dermatology 2008; Vol. 7, issue 1:35‐8. - PubMed
Sharma 2000 {published data only}
    1. Sharma PK, Yadav TP, Gautam RK, Taneja N, Satyanarayana L. Erythromycin in pityriasis rosea: a double‐blind, placebo‐controlled clinical trial. Journal of the American Academy of Dermatology 2000;42(2 Pt 1):241‐4. - PubMed
Stokholm 2016 {published data only}
    1. Stokholm J, Chawes BL, Vissing NH, Bjarnadóttir E, Pedersen TM, Vinding RK, et al. Azithromycin for episodes with asthma‐like symptoms in young children aged 1‐3 years: a randomised, double‐blind, placebo‐controlled trial. Lancet Respiratory Medicine 2016;4(1):19‐26. - PMC - PubMed
Weber 1993 {published data only}
    1. Weber K, Thurmayr R, Meisinger A. A topical erythromycin preparation and oral tetracycline for the treatment of perioral dermatitis: a placebo‐controlled trial. Journal of Dermatological Treatment 1993; Vol. 4:57‐9.
Yamamoto 1992 {published data only}
    1. Yamamoto M. Therapeutic effects of erythromycin on diffuse panbronchiolitis. A multicenter, double blind placebo‐controlled trial. Sarcoidosis 1992;9:633‐6.
Zhang 2006 {published data only}
    1. Zhang H, Kandel RP, Atakari HK, Dean D. Impact of oral azithromycin on recurrence of trachomatous trichiasis in Nepal over 1 year. British Journal of Ophthalmology 2006;90(8):943‐8. - PMC - PubMed

References to studies awaiting assessment

ACTRN12617000531314 {unpublished data only}
    1. ACTRN12617000531314. Clinical and microbiological evaluation of nonsurgical treatment of chronic periodontitis with systemically administered azithromycin [Clinical and microbiological evaluation of one‐stage full mouth disinfection in conjunction with systemically administered azithromycin: a randomised controlled clinical trial in patients with moderate to advanced chronic periodontitis]. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000531314 (first received 13 March 2017).
ChiCTR‐INR‐17013272 {unpublished data only}
    1. ChiCTR‐INR‐17013272. Adjunctive azithromycin prophylaxis for preventing cesarean scar defect [The infectious etiology of the cesarean scar defect and the prevention effect of the application of azithromycin in caesarean section]. www.chictr.org.cn/showproj.aspx?proj=22739 (first received 7 November 2017).
ChiCTR‐IOR‐16008820 {unpublished data only}
    1. ChiCTR‐IOR‐16008820. Effect of low‐dose erythromycin on the treatment of COPD [Effect of low‐dose erythromycin on the treatment of COPD]. www.chictr.org.cn/showprojen.aspx?proj=14443 (first received 11 July 2016).
CTRI/2017/07/009017 {unpublished data only}
    1. CTRI/2017/07/009017. Improved diarrhoea management for children with high risk of mortality [Antibiotics for Children with Severe Diarrhoea (ABCD) Trial]. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15841 (first received 7 July 2017).
Dicko 2016 {published data only}
    1. Dicko A, Ouedraogo JB, Zongo I, Sagara I, Cairns M, Kuepfer I, et al. A trial of seasonal malaria chemoprevention plus azithromycin in African children. American Journal of Tropical Medicine and Hygiene 2016;95(5):480‐1.
EUCTR2011‐004351‐39‐IT {unpublished data only}
    1. EUCTR2011‐004351‐39‐IT. Phase II, randomized, double arm, multi‐center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with clinical and spirometrically confirmed COPD suffering from repeated acute exacerbations [Phase II, randomized, double arm, multi‐center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with clinical and spirometrically confirmed COPD suffering from repeated acute exacerbations]. www.clinicaltrialsregister.eu/ctr‐search/trial/2011‐004351‐39/IT (first received 13 March 2012).
EUCTR2012‐002792‐34‐GB {unpublished data only}
    1. EUCTR2012‐002792‐34‐GB. The characterisation of bronchiectasis over 2 years with a trial of a low dose antibiotic in the second year with the aim of identifying characteristics that mean people show the most improvement whilst on the drug [Phenotyping bronchiectasis based on aetiology, exacerbation characteristics and response to erythromycin]. www.clinicaltrialsregister.eu/ctr‐search/trial/2012‐002792‐34/GB (first received 13 March 2014).
EUCTR2015‐004306‐42‐SI {unpublished data only}
    1. EUCTR2015‐004306‐42‐SI. Comparison of the efficacy of treatment of chronic periodontitis with scaling and root‐planning alone or in combination with azithromycin ‐ a prospective, double blind, randomised clinical trial [Comparison of the efficacy of treatment of chronic periodontitis with scaling and root‐planning alone or in combination with azithromycin ‐ a prospective, double blind, randomised clinical trial]. www.clinicaltrialsregister.eu/ctr‐search/trial/2015‐004306‐42/SI (first received 17 December 2015).
Gregersen 2017 {published data only}
    1. Gregersen H, Abildgaard N, Hieu Do T, Kristensen IB, Frølund UC, Andersen NF, et al. A randomized placebo‐controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high‐dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma. Blood 2017;130(Suppl 1):3129. - PMC - PubMed
IRCT2015052322383N1 {unpublished data only}
    1. IRCT2015052322383N1. Clinical trial azithromycin versus doxycycline chemoprophylaxis in leptospirosis in farmers [A randomized double blind placebo‐controlled trial: comparison of azithromycin with doxycycline prophylaxis against leptospirosis in human in an endemic area]. www.en.irct.ir/trial/19314 (first received 7 July 2016).
KCT0002373 {unpublished data only}
    1. KCT0002373. The efficacy and safety of azithromycin in preventing bronchopulmonary dysplasia in Ureaplasma‐positive preterm infants [The efficacy and safety of azithromycin in preventing bronchopulmonary dysplasia in Ureaplasma‐positive preterm infants: prospective, randomized, double‐blind, placebo‐controlled study]. cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=10848 (first received 7 July 2017).
Milito 2017 {published data only}
    1. Milito C, Pulvirenti F, Tabolli S, Carello R, Quinti I. Antibiotic prophylaxis in primary antibody deficiency patients: study design. Journal of Clinical Immunology 2017;37:240‐1.
    1. Milito C, Pulvirenti F, Tabolli S, Carrabba M, Fabio G, Pietrogrande M, et al. Antibiotic prophylaxis in primary antibody deficiency patients: study design. Allergy: European Journal of Allergy and Clinical Immunology 2017;72:251‐2.
NCT01270074 {unpublished data only}
    1. NCT01270074. Prevention of bronchiectasis in infants with cystic fibrosis [A Phase 3 multi‐centre randomised placebo‐controlled study of azithromycin in the primary prevention of radiologically‐defined bronchiectasis in infants with cystic fibrosis]. clinicaltrials.gov/ct2/show/record/NCT01270074 (first received 23 December 2010).
NCT01778634 {unpublished data only}
    1. NCT01778634. Trial of intravenous azithromycin to eradicate Ureaplasma respiratory tract infection in preterm infants [A Phase IIb randomized, placebo‐controlled, double‐blind trial of azithromycin to eradicate Ureaplasma respiratory tract infection in preterm infants]. clinicaltrials.gov/ct2/show/study/NCT01778634 (first received 22 January 2013).
NCT02003911 {unpublished data only}
    1. NCT02003911. Azithromycin for children hospitalized with asthma [A double‐blind, randomized, placebo‐controlled trial of azithromycin in children hospitalized with acute asthma exacerbations]. clinicaltrials.gov/ct2/show/NCT02003911 (first received 21 November 2013).
NCT02307825 {unpublished data only}
    1. NCT02307825. Azithromycin for patients with chronic rhinosinusitis failing medical and surgical therapy [Azithromycin as add‐on therapy in patients failing medical and surgical treatment for chronic rhinosinusitis: a double‐blind, randomized, placebo‐controlled trial]. clinicaltrials.gov/ct2/show/record/NCT02307825 (first received 11 November 2014).
NCT02336516 {unpublished data only}
    1. NCT02336516. Azithromycin in post diarrheal haemolytic and uremic syndrome [Azithromycin in post diarrheal haemolytic and uremic syndrome]. clinicaltrials.gov/ct2/show/record/NCT02336516 (first received 8 January 2015).
NCT02677701 {unpublished data only}
    1. NCT02677701. Testing the effect of adding chronic oral azithromycin to inhaled tobramycin in people with CF [TEACH trial: testing the effect of adding chronic azithromycin to inhaled tobramycin. A randomized, placebo‐controlled, double‐blinded trial of azithromycin 500mg thrice weekly in combination with inhaled tobramycin]. clinicaltrials.gov/ct2/show/record/NCT02677701 (first received 29 January 2016).
NCT02756403 {unpublished data only}
    1. NCT02756403. A randomized controlled trial of three antibiotic regimens for first trimester abortions [A randomized controlled trial of three prophylactic antibiotic regimens for first trimester surgical abortion]. clinicaltrials.gov/ct2/show/record/NCT02756403 (first received 20 March 2016).
NCT02911935 {unpublished data only}
    1. NCT02911935. Azithromycin to prevent wheezing following severe RSV bronchiolitis‐II [Azithromycin to prevent wheezing following severe RSV bronchiolitis‐II]. clinicaltrials.gov/ct2/show/record/NCT02911935 (first received 18 September 2016).
NCT02960503 {unpublished data only}
    1. NCT02960503. Macrolide therapy to improve forced expiratory volume in 1 second in adults with sickle cell disease [Macrolide therapy to improve forced expiratory volume in 1 second in adults with sickle cell disease: a feasibility trial]. clinicaltrials.gov/ct2/show/record/NCT02960503 (first received 2 November 2016).
NCT03130114 {unpublished data only}
    1. NCT03130114. Antibiotics for children with severe diarrhoea [Antibiotics for children with severe diarrhoea]. clinicaltrials.gov/ct2/show/record/NCT03130114 (first received 23 April 2017).
NCT03233880 {unpublished data only}
    1. NCT03233880. Impact of antichlamydial treatment on the rate of preeclampsia [Impact of antichlamydial treatment on the rate of preeclampsia among Egyptian primigravidae: a randomized controlled trial]. clinicaltrials.gov/ct2/show/record/NCT03233880 (first received 23 July 2017).
NCT03248297 {unpublished data only}
    1. NCT03248297. Antibiotic prophlaxis for high‐risk laboring women in low income countries [Azithromycin with or without amoxicillin to prevent peripartum infection and sepsis in laboring high‐risk women: 3‐arm RCT]. clinicaltrials.gov/ct2/show/record/NCT03248297 (first received 25 July 2017).
NCT03341273 {unpublished data only}
    1. NCT03341273. A randomized double‐blinded, placebo‐controlled trial of antibiotic therapy in patients with lower respiratory tract infection (LRTI) and a procalcitonin level [Targeted reduction of antibiotics using procalcitonin in a multi‐center, randomized, double‐blinded, placebo‐controlled non‐inferiority study of azithromycin treatment in outpatient adults with suspect lower respiratory tract infection (LRTI) and a procalcitonin (PCT) level of < /= 0.25 ng/mL (TRAP‐LRTI)]. clinicaltrials.gov/ct2/show/record/NCT03341273 (first received 9 November 2017).
NCT03345992 {unpublished data only}
    1. NCT03345992. Benefit of clarithromycin in patients with severe infections through modulation of the immune system [A double‐blind, randomized, placebo‐controlled clinical study of the efficacy of intravenous clarithromycin as adjunctive treatment in patients with sepsis and respiratory and multiple organ dysfunction syndrome]. clinicaltrials.gov/ct2/show/record/NCT03345992 (first received 9 November 2017).
Ramsey 2017 {published data only}
    1. Ramsey BW, Retsch‐Bogart GZ, Kloster M, Buckingham R, Hamblett NM. Efficacy and safety of azithromycin for treatment of early pseudomonas in cystic fibrosis: the optimize trial. Pediatric Pulmonology 2017;52:380‐1.
RBR‐9pqqpb {unpublished data only}
    1. RBR‐9pqqpb. Azithromycin in the treatment of chronic sinusitis: clinical and biopsy evaluation in a controlled study [Azithromycin in the treatment of eosinophilic nasossinusal polypose: clinical and histomorphological analysis in a randomized masked study with placebo]. ensaiosclinicos.gov.br/rg/RBR‐9pqqpb (first received 11 September 2017).

References to ongoing studies

Chang 2012 {published data only}
    1. Chang AB, Grimwood K, Robertson CF, Wilson AC, Asperen PP, O'Grady KA, et al. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo‐controlled trial. Trials 2012;13:156. - PMC - PubMed
Gonzalez‐Martinez 2017 {published data only}
    1. Gonzalez‐Martinez C, Kranzer K, McHugh G, Corbett EL, Mujuru H, Nicol MP, et al. Azithromycin versus placebo for the treatment of HIV‐associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial. Trials 2017;18(1):622. - PMC - PubMed
Kobbernagel 2016 {published data only}
    1. Kobbernagel HE, Buchvald FF, Haarman EG, Casaulta C, Collins AA, Hogg C, et al. Study protocol, rationale and recruitment in a European multi‐centre randomized controlled trial to determine the efficacy and safety of azithromycin maintenance therapy for 6 months in primary ciliary dyskinesia. BMC Pulmonary Medicine 2016;16:104. - PMC - PubMed
Mosquera 2016 {published data only}
    1. Mosquera RA, Gomez‐Rubio AM, Harris T, Yadav A, McBeth K, Gonzales T, et al. Anti‐inflammatory effect of pro macrolides on children with chronic lung disease: a protocol for a double‐blinded randomised controlled trial. BMJ Open 2016;6:e012060. - PMC - PubMed
Pavlinac 2017 {published data only}
    1. Pavlinac PB, Singa BO, John‐Stewart GC, Richardson BA, Brander RL, McGrath CJ, et al. Azithromycin to prevent post‐discharge morbidity and mortality in Kenyan children: a protocol for a randomised, double‐blind, placebo‐controlled trial (the Toto Bora trial). BMJ Open 2017;7:e019170. - PMC - PubMed
Vermeersch 2016 {published data only}
    1. Vermeersch K, Gabrovska M, Deslypere G, Demedts IK, Slabbynck H, Aumann J, et al. The Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator‐initiated study protocol for a multicenter, randomized, double‐blind, placebo‐controlled trial. International Journal of Chronic Obstructive Pulmonary Disease 2016;11:687‐96. - PMC - PubMed

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Ahmed 2016 [pers comm]
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Albert 2014
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Allen 2018
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Brill 2016 [pers comm]
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References to other published versions of this review

Hansen 2015
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