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

NCT01488955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2014-08-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ibuprofen

400 mg oral 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

Sponsors & Collaborators

  • University Medical Center Goettingen

    collaborator OTHER

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    lead OTHER

Principal Investigators

  • Eva Hummers-Pradier, Prof. · Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-02-28
Completion
2014-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488955 on ClinicalTrials.gov