Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01231737

Enrollment

Registered

2010-11-01

Start date

2010-11-30

Completion date

2012-02-29

Last updated

2010-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection

Keywords

Prophylasy, recurrent urinary tract infection, prulifloxacin, phosphomycin

Brief 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

Interventions

DRUGprulifloxacin

Prulifloxacin 1 tablet/week for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of urinary tract infection episodes during prophylaxis	3 months

Secondary

Measure	Time frame
improving the patient's quality of life	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026