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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)