Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin-clavulanate in the treatment of acute bacterial sinusitis.
OBJECTIVE
This study compared the clinical efficacy, time to symptom resolution, and tolerability of a 5-day regimen of telithromycin with a 10-day regimen of high-dose amoxicillin-clavulanate in acute bacterial sinusitis (ABS).


METHODS
In this multinational (41 centers in Canada, Germany, Greece, Portugal, and Turkey), open-label, noninferiority study, patients >/=18 years old (n=298) with a clinical (>7 days' symptoms) and radiological (air/fluid level, total opacification, mucosal thickening >/=10 mm) diagnosis of ABS were randomized to receive telithromycin 800 mg once daily for 5 days or amoxicillin-clavulanate 875/125 mg twice daily for 10 days. Clinical efficacy and tolerability were assessed at the test-of-cure visit (days 17-21). Time to symptom resolution was based on patients' daily diary assessment of individual symptoms.


RESULTS
The per-protocol clinical success rate (primary endpoint) with telithromycin (88.6% (109/123)) was noninferior to that with amoxicillin-clavulanate (88.8% (111/125)) (95% confidence interval: -8.9 to 8.5). In the modified intention-to-treat (mITT) population, the median time for 50% reduction of total symptom scores was significantly shorter for telithromycin (4 days) vs. amoxicillin-clavulanate (5 days; p=0.044); median times for 75% reduction of total symptom scores were: telithromycin, 7 days; amoxicillin-clavulanate, 8 days (p=0.115). The median time for reduction of total symptom scores to the absent/very mild category (mITT population) was 6 days for telithromycin vs. 8 days for amoxicillin-clavulanate (p=0.04). All treatment-emergent adverse events (TEAEs) were mostly gastrointestinal and occurred in 20.7% (30/145) of telithromycin-treated patients vs. 31.8% (47/148) of amoxicillin-clavulanate-treated patients (p=0.034). One serious AE was reported in the telithromycin group, but it was considered not to be related to treatment.


CONCLUSIONS
This open-label, randomized study demonstrated that treatment of ABS with telithromycin resulted in comparable clinical efficacy, shorter times to symptom resolution, and fewer total TEAEs than treatment with amoxicillin-clavulanate.
McGill University and University of Montreal, Montreal, Canada. desrosiers_martin@hotmail.com
Martin
M
Desrosiers
Berrylin
B
Ferguson
Jean Michel
JM
Klossek
Henri
H
Drugeon
Ralph
R
Mösges
D000208:Acute Disease; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage* / Q000494:pharmacology; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000494:pharmacology; D001424:Bacterial Infections / Q000188:drug therapy* / Q000503:physiopathology; D004334:Drug Administration Schedule; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D048628:Ketolides / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D012852:Sinusitis / Q000188:drug therapy* / Q000503:physiopathology; D013296:Streptococcus pneumoniae / Q000187:drug effects; D011795:Surveys and Questionnaires; D018440:beta-Lactam Resistance / Q000187:drug effects
D000900:Anti-Bacterial Agents; D048628:Ketolides; D000658:Amoxicillin; C106791:telithromycin