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Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

NCT ID: NCT01231737

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

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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

Detailed Description

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Conditions

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Urinary Tract Infection

Keywords

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Prophylasy recurrent urinary tract infection prulifloxacin phosphomycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prulifloxacin

Group Type ACTIVE_COMPARATOR

prulifloxacin

Intervention Type DRUG

Prulifloxacin 1 tablet/week for 12 weeks.

Interventions

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prulifloxacin

Prulifloxacin 1 tablet/week for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Of Perugia

OTHER

Sponsor Role lead

Responsible Party

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University of Perugia

Principal Investigators

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Elisabetta Costantini

Role: STUDY_CHAIR

University Of Perugia

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id