drugset / Trial / NCT01231737

Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

NCT01231737

Phase 2 Unknown 96 enrolled University Of Perugia
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2010-11
Primary completion
2011-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prulifloxacin Small molecule