Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)
- Conditions
- MedDRA - Classification Code 10046544 (Urinary infection)N39Other disorders of urinary system
- Registration Number
- DRKS00003611
- Lead Sponsor
- niversitätsmedizin Göttingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 494
Women (18 - 65 years)
- Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain
- written informed consent
- 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
- imited 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
- Not specified
- Primary Outcome Measures
Name Time Method The number of additional treatments with antibiotics combined with the number of symptoms during day 0 to day 28.<br><br>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.<br>
- Secondary Outcome Measures
Name Time Method The number of defined daily doses of antibiotics until day 28. The number of SAEs during day 28. The number of relapses during day 28. Number of patients without symptoms between day 4 and day 7. Symptom load (AUC) until day 4. symptom load until day 7. Symptom load with regard to specific symptoms until day 7. Activity impairment assessment until day 7.