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

BMC Infectious Diseases

Morten Lindbæk⁴  Lars Bjerrum⁶  Sigvard Mölstad³  Anders Bærheim²  Nils Grude¹  Marianne Bollestad⁷  Ingvild Vik⁵ 

[1] Department of Medical Microbiology, Vestfold Hospital Trust, Tønsberg, 3103, Norway;Department of Global Public Health and Primary Care, University of Bergen, Bergen, 5018, Norway;Department of Clinical Sciences, Malmoe, General Practice, University of Lund, Lund, 221 00, Sweden;Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Blindern 0318, Oslo, Norway;Department of General Practice, Oslo Accident and Emergency Out Patient Clinic, Storgata 40, Oslo, 0182, Norway;Department of Public Health, University of Copenhagen, Copenhagen, 1014, Denmark;Division of Medicine, Stavanger University Hospital, Stavanger, 4068, Norway

关键词: General practice;    Mecillinam;    Ibuprofen;    Antibiotics;    NSAID;    Cystitis;   

Others  :  1090623
DOI  :  10.1186/s12879-014-0693-y

 received in 2014-12-05, accepted in 2014-12-10,  发布年份 2014

【 摘 要 】

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 webcite.

【 授权许可】

   
2014 Vik et al.; licensee BioMed Central Ltd.

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