ANTIBIOTIC PROPHYLAXIS FOR TRANSURETHRAL PROSTATIC RESECTION MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia
Conditions
Interventions
Trade Name: UNIDROX*5CPR RIV 600MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Prulifloxacin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trade Name:
Sponsors
ANGELINI
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed