NCT01231737

Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University Of Perugia · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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: 1. 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 . 2. To assess : * Tolerability of antibiotic prophylaxis * The incidence of resistance to antibiotic therapy

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	prulifloxacin	Prulifloxacin 1 tablet/week for 12 weeks.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-02-01
• Completion: 2012-02-01
• First posted: 2010-11-01
• Last updated: 2010-11-01