Comparison of cefdinir and penicillin for the treatment of pediatric streptococcal pharyngitis.

This multicenter, randomized, controlled, investigator-masked study was performed to assess the efficacy and tolerability of cefdinir for the treatment of streptococcal pharyngitis. Children aged 1 through 12 years with signs and symptoms of pharyngitis and a positive result on a rapid screening test for Streptococcus pyogenes were randomly assigned to receive cefdinir 14 mg/kg QD, cefdinir 7 mg/kg BID, or penicillin V 10 mg/kg 4 times daily for 10 days. Seven hundred ninety-two patients were enrolled, and 682 were clinically and microbiologically assessable. All treatment groups had similar demographic characteristics (-50.0% male, predominantly white, median age 7 years). The eradication rates of S pyogenes, determined 4 to 9 days after completion of therapy, were 94.3% in the cefdinir QD group, 94.3% in the cefdinir BID group, and 70.0% in the penicillin V group (95% confidence interval [CI] 17.6%-30.9%, P < 0.001 for cefdinir QD vs penicillin; CI 17.5%-30.9%, P < 0.001 for cefdinir BID vs penicillin). Clinical cure rates were 97.4%, 96.0%, and 86.3% for the cefdinir QD, cefdinir BID, and penicillin groups, respectively (CI 6.1%-15.9%, P = 0.001 for cefdinir QD vs penicillin; CI 4.6%-14.8%, P = 0.001 for cefdinir BID vs penicillin). Adverse reactions occurred in 8.3%, 8.7%, and 7.6% of cefdinir QD, cefdinir BID, and penicillin patients, respectively (P = NS). Treatment with cefdinir, either QD or BID, was associated with higher eradication rates of S pyogenes and higher clinical cure rates. Both cefdinir and penicillin were well tolerated. Three patients, 1 receiving cefdinir BID and 2 receiving penicillin, discontinued the study drug because of adverse reactions.

RCT Entities:   Population Interventions Outcomes