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Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

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ClinicalTrials.gov Identifier: NCT01231737
Recruitment Status : Unknown
Verified October 2009 by University Of Perugia.
Recruitment status was:  Enrolling by invitation
First Posted : November 1, 2010
Last Update Posted : November 1, 2010
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: prulifloxacin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
Study Start Date : November 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Prulifloxacin Drug: prulifloxacin
Prulifloxacin 1 tablet/week for 12 weeks.

Outcome Measures

Primary Outcome Measures :
  1. number of urinary tract infection episodes during prophylaxis [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. improving the patient's quality of life [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231737

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

Responsible Party: University of Perugia
ClinicalTrials.gov Identifier: NCT01231737     History of Changes
Other Study ID Numbers: 002
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2009

Keywords provided by University Of Perugia:
recurrent urinary tract infection

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors