Comparison of 5 days of extended-release clarithromycin versus 10 days of penicillin V for the treatment of streptococcal pharyngitis/tonsillitis: results of a multicenter, double-blind, randomized study in adolescent and adult patients.
OBJECTIVE
This study compared a short-course of clarithromycin with a standard course of penicillin V in patients with tonsillopharyngitis caused by Streptococcus pyogenes.


METHODS
A total of 539 patients, aged 12-75 years, were randomized to receive either clarithromycin extended-release (ER) 500 mg once daily for 5 days or penicillin V 500 mg three times daily for 10 days in this multicenter, double-blind, parallel-group trial. Eligibility required a positive antigen test for group A beta-hemolytic streptococcus (GABHS) followed by confirmatory culture.


METHODS
Bacteriological and clinical assessments were conducted at each study visit (visit 1: study day 1; visit 2: study day 3; visit 3: study days 8-12; visit 4: study days 13-20; and visit 5: study days 40-50).


RESULTS
At the test-of-cure visit (visit 3 for clarithromycin ER patients and visit 4 for penicillin V patients) in per-protocol patients, 5 days of clarithromycin ER was comparable to 10 days of penicillin V in eradicating S. pyogenes (89% (157/177) vs 90% (139/154) respectively; 95% CI for difference (-8.2, 5.1)). Bacterial eradication was sustained in both treatment groups at the follow-up visit (88% (135/153) vs 91% (112/123) respectively; 95% CI for difference (-10.0, 4.4)). Clinical cure was achieved in > or = 94% of patients in each treatment group. The most commonly reported study drug-related adverse events (< or = 3% in either treatment group) were abdominal pain, diarrhea, dyspepsia and nausea.


CONCLUSIONS
Clarithromycin ER 500 mg once daily for 5 days is equally effective as penicillin V 500 mg three times daily for 10 days in the treatment of adolescent and adult patients with streptococcal tonsillopharyngitis.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D017291:Clarithromycin / Q000494:pharmacology / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D010404:Penicillin V / Q000494:pharmacology / Q000627:therapeutic use*; D010612:Pharyngitis / Q000188:drug therapy* / Q000382:microbiology; D013290:Streptococcal Infections / Q000188:drug therapy*; D013297:Streptococcus pyogenes / Q000187:drug effects; D014069:Tonsillitis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D017291:Clarithromycin; D010404:Penicillin V