Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI

August 7, 2014 updated by: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)

In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced.

Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Goettingen, Germany, 37073
        • Univercity Medical Center Goettingen
      • Hannover, Germany, 30625
        • MHH Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women (18 - 65 years)
  • Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain
  • written informed consent

Exclusion Criteria:

  • fever (> 38,0)
  • pain on renal bed percussion
  • signs of complicated urinary tract infection
  • urinary tract infection within the last two weeks
  • antibiotic intake within the last 7 days
  • repeated intake of pain medication (i.e. ibuprofen, diclofenac) within the last 24 hours, or continuous pain medication
  • known pregnancy/lactation period
  • current immunosuppressive therapy
  • known renal insufficiency
  • known renal abnormalities
  • current urine catheterization
  • serious neurological diseases
  • limited condition due to other disorders
  • contraindications towards trial medication
  • current/anamnestic gastrointestinal haemorrhagia
  • known allergy towards trial medication
  • current intake of drugs potentially interacting with trial medication (i.e. oral corticosteroids, anticoagulates)
  • poor communication/cooperation skills
  • disability to understand trial information, poor German language skills
  • current participation in another clinical trial or clinical trial participation within the last 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen
Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0
Drug: Ibuprofen
400 mg oral once a day from day 0 for 3 days
Experimental: Fosfomycin-Trometamol
Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
Drug: Fosfomycin-Trometamol
8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days
Other Names:
  • Monuril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of additional treatments with antibiotics combined with number of symptoms
Time Frame: day 0-28
The study outcome is considered as positive, if the interventional group where only symptoms were treated has less additional treatments with antibiotics as the interventional group, where antibiotics are given from day 0 on. Additionally, the interventional group where only symptoms were treated has to be non inferior with respect to number of symptoms.
day 0-28

Secondary Outcome Measures

Outcome Measure
Time Frame
number of defined daily doses of antibiotics
Time Frame: day 0-28
day 0-28
number of SAEs
Time Frame: day 0-28
day 0-28
number of relapses
Time Frame: day 0-28
day 0-28
number of patients without symptoms
Time Frame: day 4 and day 7
day 4 and day 7
symptom load (AUC)
Time Frame: day 0-4
day 0-4
symptom load
Time Frame: day 0-7
day 0-7
symptoms load with regard to specific symptoms
Time Frame: day 0-7
day 0-7
activity impairment assessment
Time Frame: day 0-7
day 0-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Collaborators

University Medical Center Goettingen

Investigators

  • Principal Investigator: Eva Hummers-Pradier, Prof., Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

December 7, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110512-BG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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