Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

NCT ID: NCT01849926

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

Acute Cystitis (Excl in Pregnancy)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ibuprofen

Tablet, over capsulated, 600mg three times a day for three days.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Mecillinam

Tablet, over capsulated, 200mg three times a day for three days.

Group Type: ACTIVE_COMPARATOR

Mecillinam

Intervention Type: DRUG

Interventions

Ibuprofen

Intervention Type: DRUG

Mecillinam

Intervention Type: DRUG

Other Intervention Names

Ibux; Selexid; Penomax

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Morten Lindbaek

Professor dr. med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Lindbæk, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care

Locations

University of Oslo

Oslo, , Norway

Countries

Norway

References

Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.

Reference Type: DERIVED

PMID: 39698942 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32868350 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29763434 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25516016 (View on PubMed)

Other Identifiers

UiO_IMUTI

Identifier Type: -

Identifier Source: org_study_id