A multicenter, randomized, controlled, investigator-blind study was pe
rformed to evaluate the safety and efficacy of oral cefdinir versus or
al penicillin V for the treatment of pharyngitis due to group A beta-h
emolytic 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 an
d 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 kep
t a diary to record medication intake and their assessment of throat p
ain at admission and at each day of study treatment. Five hundred fift
y-eight patients were enrolled, of whom 432 (77.4%) were clinically an
d microbiologically evaluable. The GABHS eradication rates 5 to 10 day
s 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). Clin
ical cure rates were 89.0 and 84.6%, respectively (P = 0.80). By the t
ime 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 1
8.3% 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 the
rapy for GABHS pharyngitis. Based on its twice-a-day dosage and shorte
r course of therapy, leading to potentially greater patient compliance
, cefdinir may be considered for use in the treatment of pharyngitis c
aused by GABHS.