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Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT01231737
First received: January 14, 2010
Last updated: October 29, 2010
Last verified: October 2009
History of Changes
  Purpose

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

Condition Intervention Phase
Urinary Tract Infection
 Drug: prulifloxacin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • number of urinary tract infection episodes during prophylaxis [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improving the patient's quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: November 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prulifloxacin Drug: prulifloxacin
Prulifloxacin 1 tablet/week for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231737

Sponsors and Collaborators
University Of Perugia
Investigators
Study Chair: Elisabetta Costantini University Of Perugia
  More Information

No publications provided

Responsible Party: University of Perugia
ClinicalTrials.gov Identifier: NCT01231737     History of Changes
Other Study ID Numbers: 002
Study First Received: January 14, 2010
Last Updated: October 29, 2010
Health Authority: Italy: Italian Health Ministry

Keywords provided by University Of Perugia:
Prophylasy
recurrent urinary tract infection
prulifloxacin
phosphomycin

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Fosfomycin
Fluoroquinolones
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013