A PILOT STUDY OF PRULIFLOXACIN VS. LEVOFLOXACIN IN PREVENTION OF POST-OPERATIVE URINARY BACTERIAL INFECTIONS IN PATIENTS UNDERGOING TURP - ND

Conditions: ANTIBIOTIC PROPHYLAXIS FOR TRANSURETHRAL PROSTATIC RESECTION
MedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia

Registration Number: EUCTR2006-005252-32-IT

Lead Sponsor: ANGELINI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

PATIENTS WITH NO LIMITATION OF RACE, AGED BETWEEN 40 AND 80 YEARS, PATIENTS REQUIRING TURP DUE TO BPH ACCORDING TO THE INVESTIGATOR'S OPINION, PATIENTS HAVING A PRE-OPERATIVE STERILE URINE, WRITTEN INFORMED CONSENT TO PARTECIPATE IN THE TRIAL SIGNED AND DATED BY THE PATIENT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

PERI-OPERATIVE COMPLICATIONS, PATIENTS WITH RENAL CALCULOSIS AND/OR VESICAL NEOPLASIA AND/OR VESICAL DIVERTICULA AND/OR VESICAL STONES, PATIENTS WITH INTRASURGERY EVIDENCE OF VESICAL STONES AND/OR DIVERTICULA AND/OR NEOPLASM

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO ASSESS AT V4 THE MICROBIOLOGICAL EFFICACY OF PRULIFLOXACIN COMPARED TO LEVOFLOXACIN IN THE PREVENTION OF POST-OPERATIVE URINARY BACTERIAL INFECTIONS IN PATIENTS UNDERGOING TURP;Secondary Objective: TO ASSESS AT V4 THE CLINICAL PARAMETERS IN PATIENTS UNDERGOING TURP; TO ASSESS AT V5 THE MICROBIOLOGICAL AND CLINICAL EFFICACY OF PRULIFLOXACIN COMPARED TO LEVOFLOXACIN IN PATIENTS UNDERGOING TURP; TO ASSESS THE SAFETY AND TOLERABILITY OF PRULIFLOXACIN IN COMPARISON WITH LEVOFLOXACIN;Primary end point(s): TO VERIFY THE PROPHYLACTIC EFFECT OF THE TWO TREATMENTS IN PREVENTING URINARY BACTERIAL INFECTIONS IN PATIENTS UNDERGOING TURP

Secondary Outcome Measures