Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Urinary Tract Infection Clinical Trial

Official title:

Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01231737
• Other study ID #: 002
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: January 14, 2010
• Last updated: October 29, 2010
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2009
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Italian Health Ministry
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: February 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• prulifloxacin
Prulifloxacin 1 tablet/week for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of urinary tract infection episodes during prophylaxis		3 months	No
Secondary	improving the patient's quality of life		1 year	No