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Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Primary Purpose

Urinary Tract Infection

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
prulifloxacin
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring Prophylasy, recurrent urinary tract infection, prulifloxacin, phosphomycin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Prulifloxacin

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of urinary tract infection episodes during prophylaxis

    Secondary Outcome Measures

    improving the patient's quality of life

    Full Information

    First Posted
    January 14, 2010
    Last Updated
    October 29, 2010
    Sponsor
    University Of Perugia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01231737
    Brief Title
    Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)
    Official Title
    Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    February 2011 (Anticipated)
    Study Completion Date
    February 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Of Perugia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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: 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 . To assess : Tolerability of antibiotic prophylaxis The incidence of resistance to antibiotic therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infection
    Keywords
    Prophylasy, recurrent urinary tract infection, prulifloxacin, phosphomycin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prulifloxacin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    prulifloxacin
    Intervention Description
    Prulifloxacin 1 tablet/week for 12 weeks.
    Primary Outcome Measure Information:
    Title
    number of urinary tract infection episodes during prophylaxis
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    improving the patient's quality of life
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elisabetta Costantini
    Organizational Affiliation
    University Of Perugia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

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