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Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)

Primary Purpose

Acute Cystitis (Excl in Pregnancy)

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Ibuprofen

Mecillinam

About this trial

This is an interventional treatment trial for Acute Cystitis (Excl in Pregnancy)

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ibuprofen

Mecillinam

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients who are symptom free by day four

Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.

Secondary Outcome Measures

The patients' symptom load with regard to specific symptoms.

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.

Full Information

NCT ID

NCT01849926

First Posted

April 4, 2013

Last Updated

November 1, 2017

Sponsor

University of Oslo

Collaborators

University of Bergen, Lund University, University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT01849926

Brief Title

Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

Acronym

IMUTI

Official Title

Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oslo

Collaborators

University of Bergen, Lund University, University of Copenhagen

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Cystitis (Excl in Pregnancy)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

383 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibuprofen

Arm Type

Active Comparator

Arm Description

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

Arm Title

Mecillinam

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Other Intervention Name(s)

Ibux

Intervention Type

Drug

Intervention Name(s)

Mecillinam

Other Intervention Name(s)

Selexid, Penomax

Primary Outcome Measure Information:

Title

Number of patients who are symptom free by day four

Description

Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.

Time Frame

Four days

Secondary Outcome Measure Information:

Title

The patients' symptom load with regard to specific symptoms.

Description

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.

Time Frame

Seven days

Other Pre-specified Outcome Measures:

Title

Proportion of patients who were in need of a secondary medical consult within the study period.

Time Frame

28 days

Title

Proportion of patients who developed an upper urinary tract infection (pyelonephritis).

Time Frame

14 days

Title

Proportion of patients who experienced severe adverse effects.

Time Frame

Seven days

Title

Proportion of patients who had a relapse of symptoms within four weeks after being included in the study.

Time Frame

28 days

Title

Proportion of patients with a positive urine culture after four weeks.

Time Frame

28 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morten Lindbæk, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Oslo

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

32868350

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.

Results Reference

derived

PubMed Identifier

29763434

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.

Results Reference

derived

PubMed Identifier

25516016

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.

Results Reference

derived

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Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

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