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. 2019 Sep 26;9(9):CD001860.
doi: 10.1002/14651858.CD001860.pub4.

Antibiotics for trachoma

Jennifer R Evans  1 , Anthony W Solomon, Rahul Kumar, Ángela Perez, Balendra P Singh, Rajat Mohan Srivastava, Emma Harding-Esch
Affiliations

Antibiotics for trachoma

Jennifer R Evans et al. Cochrane Database Syst Rev. .

Abstract

Background: Trachoma is the world's leading infectious cause of blindness. In 1996, WHO launched the Alliance for the Global Elimination of Trachoma by the year 2020, based on the 'SAFE' strategy (surgery, antibiotics, facial cleanliness, and environmental improvement).

Objectives: To assess the evidence supporting the antibiotic arm of the SAFE strategy by assessing the effects of antibiotics on both active trachoma (primary objective), Chlamydia trachomatis infection of the conjunctiva, antibiotic resistance, and adverse effects (secondary objectives).

Search methods: We searched relevant electronic databases and trials registers. The date of the last search was 4 January 2019.

Selection criteria: We included randomised controlled trials (RCTs) that satisfied either of two criteria: (a) trials in which topical or oral administration of an antibiotic was compared to placebo or no treatment in people or communities with trachoma, (b) trials in which a topical antibiotic was compared with an oral antibiotic in people or communities with trachoma. We also included studies addressing different dosing strategies in the population. DATA COLLECTION AND ANALYSIS: We used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach.

Main results: We identified 14 studies where individuals with trachoma were randomised and 12 cluster-randomised studies. Any antibiotic versus control (individuals)Nine studies (1961 participants) randomised individuals with trachoma to antibiotic or control (no treatment or placebo). All of these studies enrolled children and young people with active trachoma. The antibiotics used in these studies included topical (oxy)tetracycline (5 studies), doxycycline (2 studies), and sulfonamides (4 studies). Four studies had more than two study arms. In general these studies were poorly reported, and it was difficult to judge risk of bias.These studies provided low-certainty evidence that people with active trachoma treated with antibiotics experienced a reduction in active trachoma at three months (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.69 to 0.89; 1961 people; 9 RCTs; I2 = 73%) and 12 months (RR 0.74, 95% CI 0.55 to 1.00; 1035 people; 4 RCTs; I2 = 90%). Low-certainty evidence was available for ocular infection at three months (RR 0.81, 95% CI 0.63 to 1.04; 297 people; 4 RCTs; I2 = 0%) and 12 months (RR 0.25, 95% CI 0.08 to 0.78; 129 people; 1 RCT). None of these studies assessed antimicrobial resistance. In those studies that reported harms, no serious adverse effects were reported (low-certainty evidence).Oral versus topical antibiotics (individuals)Eight studies (1583 participants) compared oral and topical antibiotics. Only one study included people older than 21 years of age. Oral antibiotics included azithromycin (5 studies), sulfonamides (2 studies), and doxycycline (1 study). Topical antibiotics included (oxy)tetracycline (6 studies), azithromycin (1 study), and sulfonamide (1 study). These studies were poorly reported, and it was difficult to judge risk of bias.There was low-certainty evidence of little or no difference in effect between oral and topical antibiotics on active trachoma at three months (RR 0.97, 95% CI 0.81 to 1.16; 953 people; 6 RCTs; I2 = 63%) and 12 months (RR 0.93, 95% CI 0.75 to 1.15; 886 people; 5 RCTs; I2 = 56%). There was very low-certainty evidence for ocular infection at three or 12 months. Antimicrobial resistance was not assessed. In those studies that reported adverse effects, no serious adverse effects were reported; one study reported abdominal pain with azithromycin; one study reported a couple of cases of nausea with azithromycin; and one study reported three cases of reaction to sulfonamides (low-certainty evidence).Oral azithromycin versus control (communities)Four cluster-randomised studies compared antibiotic with no or delayed treatment. Data were available on active trachoma at 12 months from two studies but could not be pooled because of reporting differences. One study at low risk of bias found a reduced prevalence of active trachoma 12 months after a single dose of azithromycin in communities with a high prevalence of infection (RR 0.58, 95% CI 0.52 to 0.65; 1247 people). The other, lower quality, study in low-prevalence communities reported similar median prevalences of infection at 12 months: 9.3% in communities treated with azithromycin and 8.2% in untreated communities. We judged this moderate-certainty evidence for a reduction in active trachoma with treatment, downgrading one level for inconsistency between the two studies. Two studies reported ocular infection at 12 months and data could be pooled. There was a reduction in ocular infection (RR 0.36, 0.31 to 0.43; 2139 people) 12 months after mass treatment with a single dose compared with no treatment (moderate-certainty evidence). There was high-certainty evidence of an increased risk of resistance of Streptococcus pneumoniae, Staphylococcus aureus, and Escherichia coli to azithromycin, tetracycline, and clindamycin in communities treated with azithromycin, with approximately 5-fold risk ratios at 12 months. The evidence did not support increased resistance to penicillin or trimethoprim-sulfamethoxazole. None of the studies measured resistance to C trachomatis. No serious adverse events were reported. The main adverse effect noted for azithromycin (˜10%) was abdominal pain, vomiting, and nausea.Oral azithromycin versus topical tetracycline (communities)Three cluster-randomised studies compared oral azithromycin with topical tetracycline. The evidence was inconsistent for active trachoma and ocular infection at three and 12 months (low-certainty evidence) and was not pooled due to considerable heterogeneity. Antimicrobial resistance and adverse effects were not reported.Different dosing strategiesSix studies compared different strategies for dosing. There were: mass treatment at different dosing intervals; applying cessation or stopping rules to mass treatment; strategies to increase mass treatment coverage. There was no strong evidence to support any variation in the recommended annual mass treatment.

Authors' conclusions: Antibiotic treatment may reduce the risk of active trachoma and ocular infection in people infected with C trachomatis, compared to no treatment/placebo, but the size of the treatment effect in individuals is uncertain. Mass antibiotic treatment with single dose oral azithromycin reduces the prevalence of active trachoma and ocular infection in communities. There is no strong evidence to support any variation in the recommended periodicity of annual mass treatment. There is evidence of an increased risk of antibiotic resistance at 12 months in communities treated with antibiotics.

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Conflict of interest statement

Previous versions of this review

The Edna McConnell Clark Foundation supported Denise Mabey and Nicole Fraser‐Hurt for one half‐day a week over a 10‐month period to undertake the original review. SightSavers International in part funded JE's salary to update the review in 2011.

Current 2019 version of this review

JE: None known. AWS: None known. RK: None known. AP: None known. BPS: None known. RMS: None known. EHE: The International Trachoma Initiative (ITI) pays for EHE's salary. ITI is a program of The Task Force for Global Health, and receives funding from Pfizer Inc. Neither ITI nor Pfizer Inc. had any role in the review’s research questions and design; in the collection, analysis and interpretation of data; in the writing of the review; or in the decision to submit for publication.

Richard Wormald, Co‐ordinating Editor for Cochrane Eyes and Vision (CEV) signed off the review for publication. Peter Tugwell, Senior Editor and Nuala Livingstone, Associate Editor for the Cochane Musculoskeletal, Oral, Skin and Sensory (MOSS) Network reviewed a draft prior to publication. This was to avoid a potential conflict of interest as one of the authors (JE) is the joint Co‐ordinating Editor for CEV.

Figures

1
1
Study flow diagram.
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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ACT 1999 Tanzania {published and unpublished data}
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PRET Tanzania {published data only}
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PRET The Gambia {published data only}
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Resnikoff 1995 {published data only}
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TANA {published data only}
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TEF {published data only}
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References to studies excluded from this review

Abdou 2007 {published data only}
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Babbar 1982 {published data only}
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Dawson 1967b {published data only}
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Dawson 1968 {published data only}
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Dawson 1971 {published data only}
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Gower 2006 {published data only}
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NCT00286026 {published data only}
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NCT00347607 {published data only}
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NCT00347776 {published data only}
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NCT01178762 {published data only}
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NCT01767506 {published data only}
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NCT02211729 {unpublished data only}
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References to studies awaiting assessment

Last 2015 {published data only}
    1. Last A, Cassama E, Bojang E, Nabicassa M, Burr S, Thompson K, et al. Trachoma elimination in an endemic island setting in West Africa: are two doses of oral azithromycin better than one?. American Journal of Tropical Medicine and Hygiene 2015;93(Suppl 4):403‐4.

References to ongoing studies

NCT03523156 {published data only}
    1. NCT03523156. Trachoma Elimination Study by Focused Antibiotic (TESFA). clinicaltrials.gov/ct2/show/NCT03523156 (first received 14 May 2018).
SWIFT 2017 {published data only}
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References to other published versions of this review

Evans 2011
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