A multicenter, randomized, controlled, investigator-blind study was performed to evaluate the safety and efficacy of oral
cefdinir versus oral
penicillin V for the treatment of
pharyngitis due to group A beta-hemolytic streptococci (GABHS). Patients 13 years of age and older were randomized to receive either oral
cefdinir (300 mg twice a day) for 5 days followed by placebo for 5 days or oral
penicillin V (250 mg four times a day) for 10 days. Throat cultures were obtained, and signs and symptoms of
pharyngitis were recorded at study admission and follow-up visits on study days 11 to 15, 16 to 20, and 25 to 31. Patients kept a diary to record medication intake and their assessment of throat
pain at admission and at each day of study treatment. Five hundred fifty-eight patients were enrolled, of whom 432 (77.4%) were clinically and microbiologically evaluable. The GABHS eradication rates 5 to 10 days after completion of
therapy were 193 of 218 (88.5%) in the
cefdinir group and 176 of 214 (82.2%) in the
penicillin group (P = 0.053). Clinical cure rates were 89.0 and 84.6%, respectively (P = 0.80). By the time of the long-term follow-up visit, 2 to 3 weeks after completion of treatment, 156 of 191 (81.7%) of the assessable
cefdinir patients and 152 of 195 (77.9%) of the
penicillin patients remained free of GABHS. Both treatments were well tolerated, with adverse reaction rates of 18.3% in the
cefdinir study arm and 15.0% in the
penicillin study arm (P = 0.278). Five-day treatment with
cefdinir is safe and effective
therapy for GABHS
pharyngitis. Based on its twice-a-day dosage and shorter course of
therapy, leading to potentially greater patient compliance,
cefdinir may be considered for use in the treatment of
pharyngitis caused by GABHS.