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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ibuprofen

Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

400 mg oral once a day from day 0 for 3 days

Fosfomycin-Trometamol

Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days

Group Type EXPERIMENTAL

Fosfomycin-Trometamol

Intervention Type DRUG

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

Interventions

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Ibuprofen

400 mg oral once a day from day 0 for 3 days

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Monuril

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No