Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)

• ClinicalTrials.gov Identifier: NCT01849926
• Recruitment Status: Completed
• First Posted: May 9, 2013
• Last Update Posted: November 6, 2017
• Sponsor: University of Oslo
• Collaborators: University of Bergen; Lund University; University of Copenhagen
• Information provided by (Responsible Party): Morten Lindbaek, University of Oslo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Cystitis (Excl in Pregnancy)	Drug: Ibuprofen; Drug: Mecillinam	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 383 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
• Study Start Date: April 2013
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ibuprofen; Tablet, over capsulated, 600mg three times a day for three days.	Drug: Ibuprofen; Other Name: Ibux
Active Comparator: Mecillinam; Tablet, over capsulated, 200mg three times a day for three days.	Drug: Mecillinam; Other Names: Selexid; Penomax

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. Proportion of patients who were in need of a secondary medical consult within the study period. [ Time Frame: 28 days ]
2. Proportion of patients who developed an upper urinary tract infection (pyelonephritis). [ Time Frame: 14 days ]
3. Proportion of patients who experienced severe adverse effects. [ Time Frame: Seven days ]
4. Proportion of patients who had a relapse of symptoms within four weeks after being included in the study. [ Time Frame: 28 days ]
5. Proportion of patients with a positive urine culture after four weeks. [ Time Frame: 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Norway

University of Oslo

Oslo, Norway

Sponsors and Collaborators

University of Oslo

University of Bergen

Lund University

University of Copenhagen

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Morten Lindbaek, Professor dr. med, University of Oslo
• ClinicalTrials.gov Identifier: NCT01849926
• Other Study ID Numbers: UiO_IMUTI
• First Posted: May 9, 2013
• Last Update Posted: November 6, 2017
• Last Verified: November 2017

Additional relevant MeSH terms:

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Amdinocillin; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Urinary; Anti-Infective Agents; Anti-Bacterial Agents