Evaluation of 5-day therapy with telithromycin, a novel ketolide antibacterial, for the treatment of tonsillopharyngitis

• Published in: Clinical microbiology and infection Vol. 10; no. 7; pp. 615 - 623
• Main Authors: Norrby, S.R., Quinn, J., Rangaraju, M., Leroy, B.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Elsevier Ltd 01-07-2004; Blackwell Science Ltd; Blackwell
• Subjects: Adolescent; Adult; Aged; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - pharmacology; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Child; Child, Preschool; Clarithromycin - administration & dosage; Clarithromycin - pharmacology; Clarithromycin - therapeutic use; Efficacy; Female; group A β-haemolytic streptococcus; Humans; Infant; Infectious diseases; Ketolides; Macrolides - administration & dosage; Macrolides - pharmacology; Macrolides - therapeutic use; Male; Medical sciences; Microbial Sensitivity Tests; Middle Aged; Penicillin V - administration & dosage; Penicillin V - pharmacology; Penicillin V - therapeutic use; Pharmacology. Drug treatments; pharyngitis; Pharyngitis - drug therapy; Pharyngitis - microbiology; Streptococcal Infections - drug therapy; Streptococcal Infections - microbiology; Streptococcus pyogenes; Streptococcus pyogenes - drug effects; telithromycin; tonsillitis; Tonsillitis - drug therapy; Tonsillitis - microbiology; Treatment Outcome; telithromycin; Efficacy; Streptococcus pyogenes; pharyngitis; tonsillitis; group A β-haemolytic streptococcus; Telithromycin; Angina; Macrolide; Tonsillitis; Infection; Streptococcaceae; Streptococcus β hémolytique; Antibiotic; Treatment; Bacteria; Micrococcales; ENT disease; Pharynx disease; Pharyngitis; Antibacterial agent
• ISSN: 1198-743X; 1469-0691
• DOI: 10.1111/j.1469-0691.2004.00908.x

A pooled analysis of two double-blind, multicentre, Phase III studies compared oral telithromycin 800 mg once-daily for 5 days with penicillin V 500 mg three-times-daily or clarithromycin 250 mg twice-daily for 10 days in the treatment of Streptococcus pyogenes (group A β-haemolytic streptococcus; GABHS) tonsillopharyngitis. Patients aged ≥ 13 years with acute GABHS tonsillopharyngitis were randomised to receive telithromycin (n = 430), penicillin (n = 197) or clarithromycin (n = 231). Clinical isolates of S. pyogenes (n = 590) obtained from throat swab samples on study entry were tested for their in-vitro susceptibility to telithromycin, clarithromycin and azithromycin. Telithromycin demonstrated in-vitro activity against the clinical isolates of S. pyogenes (MIC50/90 0.03/0.06 mg/L) higher than clarithromycin or azithromycin (MIC50/90 0.06/0.06 mg/L and 0.12/0.25 mg/L, respectively), including erythromycin-resistant strains. At the post-therapy/test of cure (TOC) visit (days 16-23), satisfactory bacteriological outcome was demonstrated for 88.3% (234/265) and 88.6% (225/254) of telithromycin- and comparator-treated patients, respectively (per-protocol population). Overall, GABHS eradication rates were 88.7% (235/265) for telithromycin and 89.0% (226/254) for comparators. The clinical cure rates at the post-therapy/TOC visit were 93.6% (248/265) and 90.9% (220/242) for telithromycin and pooled comparators, respectively. Telithromycin was generally well-tolerated. Most adverse events considered to be possibly related to study medication were gastrointestinal and of mild intensity. Discontinuations as a result of adverse events were few in both treatment groups. In conclusion, telithromycin 800 mg once-daily for 5 days was as effective as penicillin V or clarithromycin for 10 days in the treatment of GABHS tonsillopharyngitis.