M E Pichichero1, W M Gooch. 1. Elmwood Pediatric Group and University of Rochester Medical Center, NY, USA.
Abstract
BACKGROUND: Group A beta-hemolytic streptococcal (GABHS) tonsillopharyngitis continues to be a prevalent pediatric infectious disease that requires prompt treatment for relief of symptoms and to prevent complications. OBJECTIVE: To compare the efficacy/tolerability of cefdinir and penicillin V in the treatment of pediatric GABHS tonsillopharyngitis as demonstrated in two clinical trials of similar design. DESIGN: Multicenter, randomized, investigator-blinded trials. PATIENTS: Children < or =12 years of age with sore throat, pharyngeal erythema and positive rapid streptococcal antigen test results. INTERVENTION: In Study A patients took cefdinir 7 mg/kg twice daily or 14 mg/kg once daily or penicillin V 10 mg/kg 4 times daily (all regimens for 10 days). In Study B patients took cefdinir 7 mg/kg twice daily for 5 days or penicillin V 10 mg/kg 4 times daily for 10 days. MEASUREMENTS: Clinical and microbiologic evaluations were conducted at multiple times during and after therapy. RESULTS: Of 1274 patients 1122 were evaluable (679 patients receivedcefdinir; 443 received penicillin V). Clinical cure and microbiologic eradication rates were superior in the combined cefdinir treatment groups (94.9 and 92.7%, respectively), whether given once or twice daily for 10 days or twice daily for 5 days, compared with the penicillin treatment group (88.5 and 70.9%, respectively; P<0.001 for both). Adverse event rates were comparable in the 2 groups. CONCLUSION:Cefdinir is a reliable and well-tolerated drug for the management of GABHS tonsillopharyngitis in children.
RCT Entities:
BACKGROUND: Group A beta-hemolytic streptococcal (GABHS) tonsillopharyngitis continues to be a prevalent pediatric infectious disease that requires prompt treatment for relief of symptoms and to prevent complications. OBJECTIVE: To compare the efficacy/tolerability of cefdinir and penicillin V in the treatment of pediatric GABHS tonsillopharyngitis as demonstrated in two clinical trials of similar design. DESIGN: Multicenter, randomized, investigator-blinded trials. PATIENTS: Children < or =12 years of age with sore throat, pharyngeal erythema and positive rapid streptococcal antigen test results. INTERVENTION: In Study A patients took cefdinir 7 mg/kg twice daily or 14 mg/kg once daily or penicillin V 10 mg/kg 4 times daily (all regimens for 10 days). In Study B patients took cefdinir 7 mg/kg twice daily for 5 days or penicillin V 10 mg/kg 4 times daily for 10 days. MEASUREMENTS: Clinical and microbiologic evaluations were conducted at multiple times during and after therapy. RESULTS: Of 1274 patients 1122 were evaluable (679 patients received cefdinir; 443 received penicillin V). Clinical cure and microbiologic eradication rates were superior in the combined cefdinir treatment groups (94.9 and 92.7%, respectively), whether given once or twice daily for 10 days or twice daily for 5 days, compared with the penicillin treatment group (88.5 and 70.9%, respectively; P<0.001 for both). Adverse event rates were comparable in the 2 groups. CONCLUSION:Cefdinir is a reliable and well-tolerated drug for the management of GABHS tonsillopharyngitis in children.
Authors: Paola Pansa; Yingfen Hsia; Julia Bielicki; Irja Lutsar; A Sarah Walker; Mike Sharland; Laura Folgori Journal: Drugs Date: 2018-02 Impact factor: 9.546