A prospective, randomized, open-label, active-controlled study in adult subjects with acute bacterial sinusitis comparing the clinical efficacy of telithromycin (KETEK®) 800 mg once a day for 5 days versus amoxicillin-clavulanic acid (AUGMENTIN®) 875/125 mg twice a day for 10 days.
- Conditions
- acute bacterial sinusitis (ABS)MedDRA version: 7.0Level: LLTClassification code 10000858
- Registration Number
- EUCTR2004-001460-42-DE
- Lead Sponsor
- Aventis Intercontinental - Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 298
Clinical diagnosis of ABS (signs and symptoms lasting longer than 7 days and less than 28 days, purulent anterior or posterior nasal discharge, one additional major sign and symptom or two minor signs and symptoms.
The major and minor signs and symptoms will be defined as the following: Major signs and symptoms: facial pain / pressure / tightness over the maxillary sinuses, nasal congestion / obstruction, change in the perception of smell (hypoanosmia / anosmia), fever (temperature > 38° C [100.4 F] (oral) / > 38.5° C [101.2 F] (tympanic) / > 39° C [102.2 F] (rectal)),
Minor signs and symptoms: headache, halitosis, dental pain, ear pressure/fullness, cough, fatigue,and radiological confirmation of diagnosis (presence of air/fluid level,total opacification,mucosal thickening > 10 mm)
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
Recurrent sinusitis, sinusitis requiring other treatment than antibiotherapy, previous antibiotherapy in the last 30 days, previous corticotherapy, sinus surgery, sinus puncture / lavage in the last 7 days, known major obstructive anatomic / functional lesions in nasopharynx, symptomatic allergic sinusitis and / or rhinitis …
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate that the clinical efficacy of Ketek® 800 mg OD for 5 days is noninferior to Augmentin® 875/125 mg BID for 10 days at the test of cure visit (Day 17-21).;Secondary Objective: time of resolution of sinusitis signs and symptoms, bacteriologic outcome, safety, Health economic and quality of life outcomes;Primary end point(s): Clinical efficacy at Test of Cure visit (Days 17-21) in per protocol population
- Secondary Outcome Measures
Name Time Method