EUCTR2006-001837-16-ROActive, not recruitingPhase 1
Prulifloxacin versus Levofloxacin in patients with Acute Bacterial Rhinosinusitis (ABRS)
ACRAF S.p.A.0 sites284 target enrollmentStarted: November 25, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 284
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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
Investigators
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