Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults
The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given twice daily for seven days in the treatment of adult patients with microbiologically confirmed uncomplicated urinary tract infection.
Additional study objectives are to evaluate clinical efficacy as well as safety and tolerability of the nitrofurantoin formulation.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Study on the Bacteriological and Clinical Efficacy and Safety of a Nitrofurantoin Formulation Given Twice Daily (Bid) for Seven Days in Uncomplicated Urinary Tract Infection in Adults|
- Evaluation of bacteriological efficacy [ Time Frame: after 12-42 days ] [ Designated as safety issue: No ]Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.
- Evaluation of clinical efficacy [ Time Frame: after 12-42 days ] [ Designated as safety issue: No ]Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).
- Evaluation of safety and tolerability [ Time Frame: 1-42 days ] [ Designated as safety issue: No ]Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events
|Study Start Date:||January 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Adult patients with a microbiologically confirmed uncomplicated urinary tract infection
100 mg retard capsules to be taken twice daily for seven days
Other Name: Uvamin retard