- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01231737
Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)
Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
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
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Prulifloxacin
|
Prulifloxacin 1 tablet/week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of urinary tract infection episodes during prophylaxis
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improving the patient's quality of life
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elisabetta Costantini, University Of Perugia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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