Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)
Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended.
Aims of the study:
To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):
- in reducing the number of urinary tract infection episodes during prophylaxis
- in reducing the number of urinary tract infection episodes after prophylaxis
- in improving the patient's quality of life .
To assess :
- Tolerability of antibiotic prophylaxis
- The incidence of resistance to antibiotic therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection|
- number of urinary tract infection episodes during prophylaxis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- improving the patient's quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Prulifloxacin||
Prulifloxacin 1 tablet/week for 12 weeks.