title: Efficacy of short-course therapy with the ketolide telithromycin compared with 10 days of penicillin V for the treatment of pharyngitis/tonsillitis.
abstract: This randomized, double-blind study compared the efficacy and safety of a 5-d course of the new ketolide antimicrobial, telithromycin, with those of a standard 10-d course of penicillin V (phenoxymethylpenicillin) in patients with group A beta-hemolytic streptococci (GABHS) pharyngitis/tonsillitis. Patients aged 15-65 y (n = 395) with clinical signs and symptoms of pharyngitis/tonsillitis and a positive streptococcal antigen test or throat culture for GABHS were randomized to receive either telithromycin 800 mg once daily for 5 d (n = 198) or penicillin V 500 mg three times daily for 10 d (n = 197). Clinical and bacteriologic outcomes were assessed at post-therapy, test-of-cure (Days 16-20) and late post-therapy (Days 38-45) visits. Telithromycin for 5 d was equivalent to 10 d of penicillin V in terms of bacteriologic and clinical outcome (per-protocol): at post-therapy, test-of-cure visit, bacteriologic outcome was satisfactory in 84.3% and 89.1% of patients in the telithromycin and penicillin V groups, respectively, while clinical cure was achieved in 94.8% and 94.1% of patients, respectively. At late post-therapy, 82.4% of patients treated with telithromycin achieved a satisfactory bacteriologic outcome, compared with 84.7% of penicillin V recipients. The GABHS eradication rates for telithromycin and penicillin post-therapy were 85.2% and 89.1%, respectively, and 86.1% and 86.5%, respectively at late post-therapy. Both treatments were well tolerated, with a similar overall incidence of treatment-emergent adverse events. Short-course (5 d) therapy with telithromycin 800 mg once daily is comparable to a standard 10 d course of penicillin V for the treatment of GABHS pharyngitis/tonsillitis in adults and adolescents.
authors.affiliation: Swedish Institute for Infectious Disease Control, Solna. Ragnar.Norrby@smi.ki.se
authors.forename: S R
authors.initials: SR
authors.lastname: Norrby
authors.forename: W J
authors.initials: WJ
authors.lastname: Rabie
authors.forename: P
authors.initials: P
authors.lastname: Bacart
authors.forename: O
authors.initials: O
authors.lastname: Mueller
authors.forename: B
authors.initials: B
authors.lastname: Leroy
authors.forename: M
authors.initials: M
authors.lastname: Rangaraju
authors.forename: E
authors.initials: E
authors.lastname: Butticaz-Iroudayassamy
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D048628:Ketolides; D018942:Macrolides; D008297:Male; D008875:Middle Aged; D010404:Penicillin V / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use*; D010612:Pharyngitis / Q000188:drug therapy* / Q000382:microbiology; D013290:Streptococcal Infections / Q000188:drug therapy*; D013297:Streptococcus pyogenes; D014069:Tonsillitis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D048628:Ketolides; D018942:Macrolides; D010406:Penicillins; C106791:telithromycin; D010404:Penicillin V