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

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• 作者：Ingvild Vik ; Marianne Bollestad ; Nils Grude ; Anders B?rheim…
• 关键词：Cystitis ; NSAID ; Antibiotics ; Ibuprofen ; Mecillinam ; General practice
• 刊名：BMC Infectious Diseases
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：14
• 期：1
• 全文大小：208 KB
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• 刊物主题：Infectious Diseases; Parasitology; Medical Microbiology; Tropical Medicine; Internal Medicine;
• 出版者：BioMed Central
• ISSN：1471-2334

文摘

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.