Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

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

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

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: prulifloxacin

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prulifloxacin	Drug: prulifloxacin; Prulifloxacin 1 tablet/week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of urinary tract infection episodes during prophylaxis	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
improving the patient's quality of life	1 year

Collaborators and Investigators

• Sponsor: University Of Perugia
• Investigators: Study Chair: Elisabetta Costantini, University Of Perugia

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: January 14, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2010
• Last Update Submitted That Met QC Criteria: October 29, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: prulifloxacin; recurrent urinary tract infection; Prophylasy; phosphomycin
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Prulifloxacin
• Other Study ID Numbers: 002 (University of CT Health Center)