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Table 1 Antibiotics vs. ibuprofen for the treatment of uncomplicated urinary tract infection:A clinical trial in general practices

From: Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices

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)