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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01231737
Study type Interventional
Source University Of Perugia
Contact
Status Enrolling by invitation
Phase Phase 2
Start date November 2010
Completion date February 2012

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