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

• Published in: Current medical research and opinion Vol. 19; no. 5; pp. 421 - 429
• Main Authors: Takker, Urmas, Dzyublyk, Oleksandr, Busman, Todd, Notario, Gerard
• Format: Journal Article
• Language: English
• Published: Reading Informa UK Ltd 2003; Taylor & Francis; Librapharm; Informa Healthcare
• Subjects: Adolescent; Adult; Aged; Analysis of Variance; Anti-Bacterial Agents - pharmacology; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotic therapy; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Child; Clarithromycin; Clarithromycin - pharmacology; Clarithromycin - therapeutic use; Delayed-Action Preparations; Double-Blind Method; Drug Resistance, Bacterial; GABHS; Humans; Medical sciences; Middle Aged; Patient Compliance; Penicillin; Penicillin V - pharmacology; Penicillin V - therapeutic use; Pharmacology. Drug treatments; Pharyngitis - drug therapy; Pharyngitis - microbiology; Streptococcal Infections - drug therapy; Streptococcus pyogenes; Streptococcus pyogenes - drug effects; Tonsillitis - drug therapy; Tonsillitis - microbiology; Tonsillopharyngitis; Treatment Outcome; Clarithromycin; Multicenter study; Slow release form; Processing time; Tonsillitis; Randomization; Penicillin; Bacteria; Micrococcales; ENT disease; Adult; Clinical trial; Streptococcus pyogenes; Pharynx disease; Human; Antibiotic therapy; Macrolide; Infection; Streptococcaceae; Antibiotic; Chemotherapy; Treatment; GABHS; Adolescent; Double blind study; Dosage form; Pharyngitis; Antibacterial agent; Comparative study; Tonsillopharyngitis
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079903125002027

SUMMARY Objective: This study compared a short-course of clarithromycin with a standard course of penicillin V in patients with tonsillopharyngitis caused by Streptococcus pyogenes. Research design and 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. Main outcome measures: 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 > 94% of patients in each treatment group. The most commonly reported study drug-related adverse events (< 3% in either treatment group) were abdominal pain, diarrhea, dyspepsia and nausea. Conclusion: 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.