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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01231737
Other study ID # 002
Secondary ID
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


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
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