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

Phase 4

Completed

• Conditions: Urinary Tract Infection
• Interventions: Drug: Fosfomycin-Trometamol; Drug: Ibuprofen

• Registration Number: NCT01488955
• Lead Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-08
• Study Start: 2012-02
• Primary Completion: 2014-02
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 494

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fosfomycin-Trometamol	Fosfomycin-Trometamol	Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days
Ibuprofen	Ibuprofen	Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0

Primary Outcome Measures

Name	Time	Method
number of additional treatments with antibiotics combined with number of symptoms	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Univercity Medical Center Goettingen; 🇩🇪 Goettingen, Germany

MHH Hannover; 🇩🇪 Hannover, Germany