PRULIFLOXACIN VERSUS LEVOFLOXACIN IN PATIENTS WITH ACUTE BACTERIAL RHINOSINUSITIS ABRS - ND

Conditions: ACUTE BACTERIAL RHINOSINUSITIS
MedDRA version: 6.1Level: PTClassification code 10001076

Registration Number: EUCTR2006-001837-16-IT

Lead Sponsor: ANGELINI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 284

Inclusion Criteria

MALE OR FEMALE ADULTS WITH NO LIMITATION OF RACE; ABRS DEFINED AS A VIRAL UPPER RESPIRATORY TRACT INFECTION CHARACTERIZED BY INCREASE OF SYMPTOMS AFTER 5 DAYS, OR PERSISTENT SYMPTOMS FOR 10 DAYS BEFORE THE SCREENING VISIT, WITH LESS THAN 12 WEEKS DURATION; CLINICAL DIAGNOSIS OF ABRS CHARACTERIZED BY THE PRESENCE OF TWO OR MORE OF NASAL BLOCKAGE/CONGESTION, DISCHARGE ANTERIOR/POST NASAL DRIP, FACIAL PAIN/PRESSURE, REDUCTION/LOSS OF SMELL; CLINICAL DIAGNOSIS OF MODERATE/SEVERE ABRS; WRITTEN INFORMED CONSENT
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

HYPERSENSITIVITY OR ALLERGY TO FLUOROQUINOLONE ANTIBACTERIALS AND/OR TO ANY COMPONENT, NOSOCOMIAL SINUS INFECTION OR INFECTIONS FOLLOWING OR ASSOCIATED WITH NASO-TRACHEAL INTUBATION, CHRONIC OR COMPLICATED RHINOSINUSITIS, NASAL POLYPS, HISTORY OF SINUS SURGERY.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO EVALUATE AT THE TEST OF CURE TOC VISIT, THE CLINICAL EFFICACY OF PRULIFLOXACIN IN COMPARISON WITH LEVOFLOXACIN IN THE TREATMENT OF PATIENTS WITH ACUTE BACTERIAL RHINOSINUSITIS;Secondary Objective: TO EVALUATE IN COMPARISON WITH LEVOFLOXACIN THE QUALITY OF LIFE QOL ; THE EFFICACY IN MAINTAINING THE PATIENT FREE FROM SIGN OR SYMPTOM OF BACTERIAL RHINOSINUSITIS AT THE LATE POST THERAPY FOLLOW-UP; THE SAFETY OF THE STUDY DRUGS; THE CLINICAL GLOBAL IMPRESSION;Primary end point(s): EVALUATION AT TOC VISIT, 4-8 DAYS AFTER THE END OF TREATMENT, OF THE CLINICAL EFFICACY OF PRULIFLOXACIN 600 MG UID VS LEVOFLOXACIN 500 MG UID IN THE TREATMENT OF PATIENTS WITH ABRS

Secondary Outcome Measures