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
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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: prulifloxacin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Active Comparator: Prulifloxacin||
Prulifloxacin 1 tablet/week for 12 weeks.
- number of urinary tract infection episodes during prophylaxis [ Time Frame: 3 months ]
- improving the patient's quality of life [ Time Frame: 1 year ]
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
|Study Chair:||Elisabetta Costantini||University Of Perugia|