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

Institut für anwendungsorientierte Forschung und klinische Studien

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infection

Treatments: Drug: Ibuprofen; Drug: Fosfomycin-Trometamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01488955

20110512-BG

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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494 participants in 2 patient groups

Ibuprofen

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen

Fosfomycin-Trometamol

Experimental group

Description:

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

Treatment:

Drug: Fosfomycin-Trometamol