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Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

NCT01231737 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2010-11-01

No results posted yet for this study

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

Interventions

DRUG

prulifloxacin

Prulifloxacin 1 tablet/week for 12 weeks.

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Principal Investigators

  • Elisabetta Costantini · University Of Perugia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-02-28
Completion
2012-02-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01231737 on ClinicalTrials.gov