Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

University Of Perugia

Status and phase

Unknown

Phase 2

Conditions

Urinary Tract Infection

Treatments

Drug: prulifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01231737

002

Details and patient eligibility

About

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:

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 .
To assess :
- Tolerability of antibiotic prophylaxis
- The incidence of resistance to antibiotic therapy

Enrollment

96 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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