Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Of Perugia
• Treatments: Fluoroquinolones; Fosfomycin; Prulifloxacin

Criteria

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