Prulifloxacin versus Levofloxacin in patients with Acute Bacterial Rhinosinusitis (ABRS)
- Conditions
- Acute Bacterial Rhinosinusitis
- Registration Number
- EUCTR2006-001837-16-HU
- Lead Sponsor
- Angelini Farmaceutici
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 284
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 blockade/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
Hypersensitivity or allergy to Fluorquinolone antibacterials and/or 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 signs or symptoms 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
Name Time Method