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
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
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
NCT ID
NCT01231737
First Posted
January 14, 2010
Last Updated
October 29, 2010
Sponsor
University Of Perugia
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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