Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)
Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficient as treatment with mecillinam in this group.
Acute Cystitis (Excl in Pregnancy)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women|
- Number of patients who are symptom free by day four [ Time Frame: Four days ] [ Designated as safety issue: No ]Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.
- The patients' symptom load with regard to specific symptoms. [ Time Frame: Seven days ] [ Designated as safety issue: No ]Specific symptoms, such as dysuria, urgency and pollakiuria, will be given a number from 0-6 in the patient diary, 0 = no problem and 6= as bad as it can get.
- Proportion of patients who were in need of a secondary medical consult within the study period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Proportion of patients who developed an upper urinary tract infection (pyelonephritis). [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Proportion of patients who experienced severe adverse effects. [ Time Frame: Seven days ] [ Designated as safety issue: No ]
- Proportion of patients who had a relapse of symptoms within four weeks after being included in the study. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Proportion of patients with a positive urine culture after four weeks. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Ibuprofen
Tablet, over capsulated, 600mg three times a day for three days.
Active Comparator: Mecillinam
Tablet, over capsulated, 200mg three times a day for three days.
The design of the study will be a double blinded randomized controlled trial (RCT). Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).
Urine cultures will be obtained on day one and after two weeks. The patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. We will contact the patients after two weeks to make sure they have followed the study procedures. After four weeks we will perform a final interview with the patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849926
|Contact: Ingvild Vik, Cand. med.||+47 firstname.lastname@example.org|
|University of Oslo||Recruiting|
|Principal Investigator:||Morten Lindbæk, Professor||University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care|