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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Prulifloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014