Five day clarithromycin modified release versus 10 day penicillin V for group A streptococcal pharyngitis: a multi-centre, open-label, randomized study.

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. CONCLUSION 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.

[1]  E. Bingen,et al.  Genetic and phenotypic characterization of macrolide resistance in group A streptococci isolated from adults with pharyngo-tonsillitis in France. , 2001, The Journal of antimicrobial chemotherapy.

[2]  É. Bingen,et al.  Traitement des angines aiguës à streptocoque β-hémolytique du groupe A chez l’enfant par la josamycine pendant cinq jours , 2001 .

[3]  E. Bingen,et al.  Resistance to Macrolides in Streptococcus pyogenes in France in Pediatric Patients , 2000, Antimicrobial Agents and Chemotherapy.

[4]  D. Low.  Trends and significance of antimicrobial resistance in respiratory pathogens. , 2000, Current opinion in infectious diseases.

[5]  H. Scholz,et al.  Comparison of short-course (5 day) cefuroxime axetil with a standard 10 day oral penicillin V regimen in the treatment of tonsillopharyngitis. , 2000, The Journal of antimicrobial chemotherapy.

[6]  S. Holm.  Treatment of recurrent tonsillopharyngitis. , 2000, The Journal of antimicrobial chemotherapy.

[7]  J. Hedrick,et al.  Clarithromycin suspension vs penicillin V suspension in children with streptococcal pharyngitis , 2000, Advances in therapy.

[8]  J. Picazo,et al.  Incidence of erythromycin resistance in Streptococcus pyogenes: a 10-year study. , 1999, Diagnostic microbiology and infectious disease.

[9]  G. Cornaglia,et al.  Resistance of Streptococcus pyogenes to erythromycin and related antibiotics in Italy. The Italian Surveillance Group for Antimicrobial Resistance. , 1998, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[10]  E. Pérez-Trallero,et al.  Erythromycin resistance of Streptococcus pyogenes in Madrid. , 1998, The Pediatric infectious disease journal.

[11]  W. Gooch,et al.  Five-Day Cefdinir Treatment for Streptococcal Pharyngitis , 1998, Antimicrobial Agents and Chemotherapy.

[12]  U. Schaad,et al.  Evaluation of the efficacy, safety and toleration of azithromycin vs. penicillin V in the treatment of acute streptococcal pharyngitis in children: results of a multicenter, open comparative study. The Swiss Tonsillopharyngitis Study Group. , 1996, The Pediatric infectious disease journal.

[13]  E. Bingen,et al.  Six-day amoxicillin vs. ten-day penicillin V therapy for group A streptococcal tonsillopharyngitis. , 1996, The Pediatric infectious disease journal.

[14]  L. Pacifico,et al.  Comparative efficacy and safety of 3-day azithromycin and 10-day penicillin V treatment of group A beta-hemolytic streptococcal pharyngitis in children , 1996, Antimicrobial agents and chemotherapy.

[15]  P. Geslin,et al.  6-Day Amoxicillin Versus 10-day Penicillin V for Group A β-Haemolytic Streptococcal Acute Tonsillitis in Adults: A French Multicentre, Open-label, Randomized Study , 1996 .

[16]  A. Scheimberg,et al.  Josamycine 5 jours versus pénicilline V 10 jours dans le traitement des angines aiguës à streptocoque bêta-hémolytique du groupe A , 1995 .

[17]  J. Still.  Management of pediatric patients with group A beta‐hemolytic Streptococcus pharyngitis: treatment options , 1995 .

[18]  E. Bingen,et al.  Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children. , 1995, The Pediatric infectious disease journal.

[19]  H. Portier,et al.  Five versus ten days treatment of streptococcal pharyngotonsillitis: a randomized controlled trial comparing cefpodoxime proxetil and phenoxymethyl penicillin. , 1994, Scandinavian journal of infectious diseases.

[20]  C. Schrock.  Clarithromycin vs penicillin in the treatment of streptococcal pharyngitis. , 1992, The Journal of family practice.

[21]  F. Scaglione.  Comparison of the clinical and bacteriological efficacy of clarithromycin and erythromycin in the treatment of streptococcal pharyngitis. , 1990, Current medical research and opinion.

[22]  J. Gouyon,et al.  Five day treatment of pharyngotonsillitis with cefpodoxime proxetil. , 1990, The Journal of antimicrobial chemotherapy.

[23]  O. Cars,et al.  Five versus ten days treatment of group A streptococcal pharyngotonsillitis: a randomized controlled clinical trial with phenoxymethylpenicillin and cefadroxil. , 1988, Scandinavian journal of infectious diseases.

[24]  R. Schwartz,et al.  Penicillin V for group A streptococcal pharyngotonsillitis. A randomized trial of seven vs ten days' therapy. , 1981, JAMA.