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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001460-42-DE
Enrollment
298
Registered
2004-09-16
Start date
2004-11-16
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 sinusitis (ABS) MedDRA version: 7.0 Level: LLT Classification code 10000858

Interventions

Trade Name: Ketek Product Name: Ketek (telithromycin) Product Code: HMR 3647A/4023 Pharmaceutical Form: Tablet INN or Proposed INN: telithomycin Other descriptive name: Ketek Concentration unit: mg mi

Sponsors

Aventis Intercontinental - Sanofi-aventis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 …

Design outcomes

Primary

MeasureTime frame
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—

Countries

Germany

Outcome results

None listed

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