Protocol number | HWI-01 |
---|---|
EudraCT registration | 2006-006398-26 |
Trial sites | • 19 general practices in and around Hannover |
• 12 general practices in and around Göttingen | |
Time period | 2007/2008 |
Trial design | • Double blind, multicentre, randomised controlled clinical equivalence trial, investigator initiated |
Objectives | • To describe a first trend concerning the equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection |
• To optimize documents and procedures of a double-blind, randomised-controlled trial in German general practices | |
• To assess the number of treatment failures within the ibuprofen group | |
Condition | • Acute uncomplicated urinary tract infection |
Endpoints | • Symptom resolution on day 4/7, symptom relief on day 4 |
• Treatment failure in the ibuprofen group | |
Number of patients | • 79 patients were included |
Inclusion criteria | • Women aged ≥ 18 years, written informed consent |
• Symptoms of urinary tract infection (dysuria, frequency, urgency, possible low abdominal pain) | |
Exclusion criteria | • Any signs indicating a complicated UTI (i.e. fever, back pain) |
• Any conditions that may lead to complicated infections (i.e. pregnancy, diabetes, renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, immunosuppressive therapy, other serious diseases, cancer), | |
• Previous urinary tract infection within the last two weeks, | |
• Current use of antibiotics or non-steroidal anti-inflammatory drugs, | |
• History of gastrointestinal ulcers; epilepsy, allergies or other | |
• contraindications for trial drugs, | |
• Inability to understand the trial information or to give informed consent | |
Ethics approval | • Research Ethics Committee of the University of Goettingen Medical Center (2007/06/13) |
• Trial conduct according to ICH-GCP-guidelines and the Declaration of Helsinki | |
Treatment plan | • First arm: ibuprofen 3 × 400 mg/3 days |
• Second arm: ciprofloxacin 2 × 250 mg, 1 × placebo/3 days | |
Funding | • German Federal Ministry of Research and Technology (BMBF) |