[Efficacy and safety of telithromycin in the treatment of acute maxillary sinusitis].

Abstract

UNLABELLED:

The aim of this study was to evaluate the efficacy and tolerance of 5 days of telithromycin (800 mg once a day) in the treatment of bacteriologically proven acute maxillary sinusitis (AMS).

DESIGN:

Two hundred and sixty-three patients with a clinically diagnosed AMS and purulent rhinorrhea were included in this prospective, multicenter, non-comparative open-labeled French study. Pus was sampled from the middle meatus before inclusion. The bacterial origin of the infection was confirmed by a scientific committee (presence of leucocytes/bacteria on direct microscopic examination of pus, and positive culture).

RESULTS:

Seven to 14 days after the end of the treatment the clinical success rate (cure and improvement) was 91% (63/69 patients) in the per protocol bacteriologically documented (PPb) population and 90% (231/257 patients) in the modified intent-to-treat population. The main strains identified in the 69 patients of PPb population were Streptococcus pneumoniae (47.8%, of which 15 strains with reduced susceptibility to penicillin and 15 erythromycin resistant strains), Haemophilus influenzae (14.5%), Branhamella catarrhalis (8.7%) and Streptococcus aureus (29.0%). Drug tolerance was assessed on 263 patients as satisfactory with mainly gastro-intestinal disorders considered to be related to the treatment in 7.6% of patients. No serious adverse event related to the study drug was reported.

CONCLUSION:

The efficacy of telithromycin 800 mg once daily for 5 days is confirmed in the treatment of AMS, even for those due to S. Pneumoniae.

• Authors: C Dubreuil, D Ebbo, F Goldstein, Groupe investigateurs
• Journal: Medecine et maladies infectieuses (Med Mal Infect) Vol. 35 Issue 4 Pg. 197-204 (Apr 2005) ISSN: 0399-077X [Print] France
• Vernacular Title: Efficacité et tolérance de la télithromycine dans le traitement des sinusites maxillaires aiguës.
• PMID: 15914288 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Anti-Bacterial Agents
• Ketolides
• telithromycin

Topics

• Acute Disease
• Adult
• Anti-Bacterial Agents (therapeutic use)
• Bacterial Infections (classification, drug therapy)
• Female
• France
• Humans
• Ketolides (therapeutic use)
• Male
• Maxillary Sinusitis (drug therapy)
• Recurrence
• Reproducibility of Results
• Safety