Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Phase 2

• Conditions: Urinary Tract Infection
• Interventions: Drug: prulifloxacin

• Registration Number: NCT01231737
• Lead Sponsor: University Of Perugia

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-10-29
• Last Update Submitted: 2010-10-29
• Study Start: 2010-11
• Study First Posted: 2010-11-01
• Last Update Posted: 2010-11-01
• Primary Completion: 2011-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Female patients
• Age over 18 years old
• No allergies to the drugs to be prescribed
• No counter-indications to this drug therapy
• Urine culture shows responsiveness to drugs at recruitment of patient
• History of urinary tract infections with at least three episodes in the previous year or two in the past six months

Exclusion Criteria

• Lack of tolerability of prescribed drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prulifloxacin	prulifloxacin	-

Primary Outcome Measures

Name	Time	Method
number of urinary tract infection episodes during prophylaxis	3 months

Secondary Outcome Measures

Name	Time	Method
improving the patient's quality of life	1 year