Clinical trial NCT01849926: Ibuprofen Versus Mecillinam for Uncomplicated Cystitis
Official title: Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Cystitis (Excl in Pregnancy)
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Lund University
name: University of Copenhagen
First posted: 2013-05-09
Enrollment: 383
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* woman between 18 and 60 years of age
* dysuria and pollakiuria and/or urinary urgency
* ability to give written consent

Exclusion Criteria:

* pregnancy/breastfeeding child under one month of age
* diabetes
* kidney disease
* organic aciduria
* clinical suspicion of pyelonephritis; fever, reduced general condition, upper back pain
* vaginal symptoms such as discharge or irritation
* severe abdominal pain
* symptoms that have lasted for more than seven days
* one or more urinary tract infections within the lasts four weeks
* permanent bladder catheter or use of bladder catheter within the last four weeks
* use of antibiotics within the last two weeks
* participated in a clinical trial within the last four weeks
* previously undergone a pyelonephritis
* previous allergic reaction to penicillin
* previous allergic reaction to ibuprofen, or worsening of asthma when using nonsteroidal antiinflammatory drugs(NSAIDs)
* narrow oesophagus
* use of the drug probenecid
* severe gastritis or previous ulcer
* anticoagulative treatment
* ongoing use of steroids
* use of immunosuppressant drugs
* thrombocytopenia,
* Chrohn's disease or Ulcerative colitis
* heart insufficiency
* severe psychiatric illness or dementia
* severe drug addiction
* unable to communicate in Norwegian, Swedish or Danish language

Primary outcomes:
measure: Number of patients who are symptom free by day four
timeFrame: Four days
Secondary outcomes:
measure: The patients' symptom load with regard to specific symptoms.
timeFrame: Seven days
Other outcomes:
measure: Proportion of patients who were in need of a secondary medical consult within the study period.
timeFrame: 28 days
measure: Proportion of patients who developed an upper urinary tract infection (pyelonephritis).
timeFrame: 14 days
measure: Proportion of patients who experienced severe adverse effects.
timeFrame: Seven days
measure: Proportion of patients who had a relapse of symptoms within four weeks after being included in the study.
timeFrame: 28 days
measure: Proportion of patients with a positive urine culture after four weeks.
timeFrame: 28 days
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care
name: Morten Lindbæk, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vik I, Mdala I, Bollestad M, Cordoba GC, Bjerrum L, Neumark T, Damsgaard E, Baerheim A, Grude N, Lindbaek M. Predicting the use of antibiotics after initial symptomatic treatment of an uncomplicated urinary tract infection: analyses performed after a randomised controlled trial. BMJ Open. 2020 Aug 30;10(8):e035074. doi: 10.1136/bmjopen-2019-035074.
citation: Vik I, Bollestad M, Grude N, Baerheim A, Damsgaard E, Neumark T, Bjerrum L, Cordoba G, Olsen IC, Lindbaek M. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women-A double-blind, randomized non-inferiority trial. PLoS Med. 2018 May 15;15(5):e1002569. doi: 10.1371/journal.pmed.1002569. eCollection 2018 May.
citation: Vik I, Bollestad M, Grude N, Baerheim A, Molstad S, Bjerrum L, Lindbaek M. Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol. BMC Infect Dis. 2014 Dec 17;14:693. doi: 10.1186/s12879-014-0693-y.