Noroxin Efficacy and Safety Trial

• Status: Unknown status
• Trial end date: 2018-07-30
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy and safety of Norfloxacin (Noroxin)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OBS Pakistan
• Treatments: Norfloxacin

Criteria

Inclusion Criteria:

• Written informed consent

• At least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis

Exclusion Criteria:

• Duration of UTI symptoms for more than 7 days before physician's visit

• Clinical signs of invasiveness such as fever (axillary body temperature >38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting

• Known or suspicion of anatomical or functional abnormality of the urinary tract

• Vaginal symptoms: discharge, irritation

• Diabetes mellitus

• Immunosuppression (e.g. prednisone equivalent >10mg per day for >14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia)

• Any other serious comorbidity as judged by the treating physician

• Bladder catheter in situ or during the past 30 days

• Pregnancy

• Recurrent urinary tract infection (more than 3 infections during the last 12 months)

• Antibiotic treatment during the last 4 weeks