A STUDY OF 5-DAY CEFDINIR TREATMENT FOR STREPTOCOCCAL PHARYNGITIS IN CHILDREN

Objective: To compare the safety and efficacy of a 5-day regimen of ce fdinir with those of a conventional 10-day regimen of penicillin V for the treatment of streptococcal pharyngitis in children. Design: Inves tigator-blind, randomized controlled trial. Setting: Primary care, amb ulatory. Patients: Children aged 1 to 12 years with signs and symptoms of pharyngitis and a positive result on a rapid screening test for St reptococcus pyogenes (ie, a convenience sample). Four hundred eighty-t wo patients were enrolled in the study, and 440 were clinically and mi crobiologically evaluable. The most common reasons patients were nonev aluable were failure to return for specified fled visits and noncompli ance with the administration of the medication; 2 patients receiving p enicillin V discontinued use of the drug because of adverse events. In tervention: Patients were randomized to receive either 7-mg/kg cefdini r, twice daily, for 5 days or 10-mg/kg penicillin V potassium, 4 times daily, for 10 days. Main Outcome Measures: The eradication of S pyoge nes and the clinical cure of the signs and symptoms of pharyngitis, bo th determined 5 to 10 days after the completion of therapy. Results: S treptococcus pyogenes was eradicated in 201 (90%) of the 224 patients receiving cefdinir and 155 (72%) of the 216 patients receiving penicil lin V (95% confidence interval [CI], 10.7%-25.1%; P < .001). The clini cal cure rates were 92% and 91% in the groups receiving cefdinir and p enicillin V, respectively (95% CI, -4.5% to 6.1%; P = .80). Adverse ev ents, regardless of the opinion of the investigator about their relati onship to the study medication, occurred in 12.5% of the patients rece iving cefdinir and 13.6% of the patients receiving penicillin V (P = . 69). Conclusions: A 5-day regimen of cefdinir eradicated a higher prop ortion of S pyogenes than a 10-day regimen of penicillin V. No differe nce was noted between the regimens for clinical outcomes or adverse ev ent rates.