Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol

Ingvild Vik^{1

2}, Marianne Bollestad^{3

4}, Nils Grude^{5

6}, Anders Bærheim⁷, Sigvard Mölstad⁸, Lars Bjerrum⁹, Morten Lindbæk¹⁰

Affiliations

¹ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. ingvild.vik@medisin.uio.no.
² Department of General Practice, Oslo Accident and Emergency Out Patient Clinic, Storgata 40, 0182, Oslo, Norway. ingvild.vik@medisin.uio.no.
³ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. marianne.bollestad@medisin.uio.no.
⁴ Division of Medicine, Stavanger University Hospital, Pb 8100, 4068, Stavanger, Norway. marianne.bollestad@medisin.uio.no.
⁵ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. nigrud@siv.no.
⁶ Department of Medical Microbiology, Vestfold Hospital Trust, Pb 2168, 3103, Tønsberg, Norway. nigrud@siv.no.
⁷ Department of Global Public Health and Primary Care, University of Bergen, Pb 7804, 5018, Bergen, Norway. Anders.Barheim@igs.uib.no.
⁸ Department of Clinical Sciences, Malmoe, General Practice, University of Lund, box 117, 221 00, Lund, Sweden. sigvard.molstad@med.lu.se.
⁹ Department of Public Health, University of Copenhagen, Pb 2099, 1014, Copenhagen, Denmark. lbjerrum@sund.ku.dk.
¹⁰ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. morten.lindbak@medisin.uio.no.

PMID: 25516016
PMCID: PMC4273435
DOI: 10.1186/s12879-014-0693-y

Randomized Controlled Trial

Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol

Ingvild Vik et al. BMC Infect Dis. 2014.

. 2014 Dec 17:14:693.

doi: 10.1186/s12879-014-0693-y.

Authors

Ingvild Vik^{1

2}, Marianne Bollestad^{3

4}, Nils Grude^{5

6}, Anders Bærheim⁷, Sigvard Mölstad⁸, Lars Bjerrum⁹, Morten Lindbæk¹⁰

Affiliations

¹ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. ingvild.vik@medisin.uio.no.
² Department of General Practice, Oslo Accident and Emergency Out Patient Clinic, Storgata 40, 0182, Oslo, Norway. ingvild.vik@medisin.uio.no.
³ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. marianne.bollestad@medisin.uio.no.
⁴ Division of Medicine, Stavanger University Hospital, Pb 8100, 4068, Stavanger, Norway. marianne.bollestad@medisin.uio.no.
⁵ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. nigrud@siv.no.
⁶ Department of Medical Microbiology, Vestfold Hospital Trust, Pb 2168, 3103, Tønsberg, Norway. nigrud@siv.no.
⁷ Department of Global Public Health and Primary Care, University of Bergen, Pb 7804, 5018, Bergen, Norway. Anders.Barheim@igs.uib.no.
⁸ Department of Clinical Sciences, Malmoe, General Practice, University of Lund, box 117, 221 00, Lund, Sweden. sigvard.molstad@med.lu.se.
⁹ Department of Public Health, University of Copenhagen, Pb 2099, 1014, Copenhagen, Denmark. lbjerrum@sund.ku.dk.
¹⁰ Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway. morten.lindbak@medisin.uio.no.

PMID: 25516016
PMCID: PMC4273435
DOI: 10.1186/s12879-014-0693-y

Abstract

Background: Although uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution.

Methods/design: This is a randomized, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days. Allocation is conducted using block randomization. The primary outcome is the number of patients who feel cured by day four as recorded in a diary. Adverse events will be handled and reported in accordance with Good Clinical Practice.

Discussion: If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale.

Trial registration: EudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926.

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References

1. Hunskår S: Nyrer og Urinveier. Allmennmedisin. Volume 3. 3rd edition. Edited by Hunskår S. Gyldendal; 2013:655-59.,
1. Colgan R, Williams M. Diagnosis and treatment of acute uncomplicated cystitis. Am Fam Physician. 2011;84(7):771–776. - PubMed
1. Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol. 2000;10(8):509–515. doi: 10.1016/S1047-2797(00)00072-7. - DOI - PubMed
1. Stamm WE, McKevitt M, Roberts PL, White NJ. Natural history of recurrent urinary tract infections in women. Rev Infect Dis. 1991;13(1):77–84. doi: 10.1093/clinids/13.1.77. - DOI - PubMed
1. Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002;287(20):2701–2710. doi: 10.1001/jama.287.20.2701. - DOI - PubMed

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Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol

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Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol

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