Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)
|Acute Cystitis (Excl in Pregnancy)||Drug: Ibuprofen Drug: Mecillinam||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]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 ]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 ]
- Proportion of patients who developed an upper urinary tract infection (pyelonephritis). [ Time Frame: 14 days ]
- Proportion of patients who experienced severe adverse effects. [ Time Frame: Seven days ]
- Proportion of patients who had a relapse of symptoms within four weeks after being included in the study. [ Time Frame: 28 days ]
- Proportion of patients with a positive urine culture after four weeks. [ Time Frame: 28 days ]
|Study Start Date:||May 2013|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Ibuprofen
Tablet, over capsulated, 600mg three times a day for three days.
Other Name: Ibux
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
|University of Oslo|
|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|