title: Five day clarithromycin modified release versus 10 day penicillin V for group A streptococcal pharyngitis: a multi-centre, open-label, randomized study.
abstract: OBJECTIVE
  A multicentre, comparative, randomized, open-label, Phase III trial evaluated the efficacy and tolerability of clarithromycin modified release (MR) versus penicillin V for pharyngitis due to group A beta-haemolytic streptococci (GABHS).
  
  
  METHODS
  Three hundred and forty-nine patients (12-40 years) with acute pharyngotonsillitis and a positive Streptococcus A antigen immunoassay test were randomized to receive clarithromycin MR 500 mg od for 5 days or penicillin 590 mg tds for 10 days. Patients were clinically evaluated and a throat swab for culture obtained before treatment, after treatment (day 8 or 13 depending on the treatment arm) and at the follow-up visit (day 30). The main criterion for efficacy was the bacteriological cure rate after treatment.
  
  
  RESULTS
  Three hundred and forty-nine patients were considered for the intent-to-treat analysis. After treatment, clinical cure rates were 88.1% in the clarithromycin group and 92.4% in the penicillin group, and eradication rates were 82.8% and 83.6%, respectively. There were no statistically significant differences between the two treatments. Three hundred and three (87%) patients had a positive culture before treatment, among which 29 (9.7%) were found to be clarithromycin resistant. Two hundred and thirty-nine patients were clinically and bacteriologically evaluable for per protocol analysis. After treatment, clinical cure rates were 95.2% in the clarithromycin group and 97.3% in the penicillin group, and eradication rates were 94.4% and 92%, respectively. No statistically significant difference was shown. Adverse events occurred in 46 patients of the clarithromycin group and 31 of the penicillin group (with no statistical difference). Most of them were of mild or moderate severity.
  
  
  CONCLUSIONS
  Clarithromycin MR administered once daily for 5 days is as safe and effective as penicillin V administered three times a day for 10 days in the treatment of GABHS pharyngitis.
authors.affiliation: Dijon University Hospital, Hôpital du Bocage, Service des Maladies Infectieuses, 2 boulevard de Lattre de Tassigny, 21034, Dijon, France. henriporter@chu-dijon.fr
authors.forename: Henri
authors.initials: H
authors.lastname: Portier
authors.forename: Jamila
authors.initials: J
authors.lastname: Filipecki
authors.forename: Philippe
authors.initials: P
authors.lastname: Weber
authors.forename: Gerard
authors.initials: G
authors.lastname: Goldfarb
authors.forename: Denis
authors.initials: D
authors.lastname: Lethuaire
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Chauvin
mesh_terms: D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D016009:Chi-Square Distribution; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010404:Penicillin V / Q000008:administration & dosage* / Q000009:adverse effects; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects; D010612:Pharyngitis / Q000188:drug therapy* / Q000382:microbiology*; D013290:Streptococcal Infections / Q000188:drug therapy* / Q000382:microbiology; D013297:Streptococcus pyogenes / Q000187:drug effects*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D010406:Penicillins; D017291:Clarithromycin; D010404:Penicillin V