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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001837-16-IT

Enrollment

284

Registered

2006-06-23

Start date

2006-05-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACUTE BACTERIAL RHINOSINUSITIS MedDRA version: 6.1 Level: PT Classification code 10001076

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Prulifloxacin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- Pharmaceutical Form: Tablet INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Austria, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026