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

Study Overview
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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.

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

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Fosfomycin-Trometamol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0 | Drug: Ibuprofen<br>* 400 mg oral once a day from day 0 for 3 days<br>|
| Experimental: Fosfomycin-Trometamol<br>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<br>* 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<br>* Other names: Monuril;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial infection