A study of 5-day cefdinir treatment for streptococcal pharyngitis in children. Cefdinir Pediatric Pharyngitis Study Group
K. J. Tack, J. A. Hedrick, E. Rothstein, M. A. Nemeth, C. Keyserling and M. E. Pichichero
Parke-Davis Pharmaceutical Research, Ann Arbor, Mich, USA.
OBJECTIVE: To compare the safety and efficacy of a 5-day regimen of
cefdinir with those a conventional 10-day regimen of penicillin V for the
treatment of streptococcal pharyngitis in children. DESIGN:
Investigator-blind, randomized controlled trial. SETTING: Primary care,
ambulatory. PATIENTS: Children aged 1 to 12 years with signs and symptoms
of pharyngitis and a positive result on a rapid screening test for
Streptococcus pyogenes (ie, a convenience sample). Four hundred eighty-two
patients were enrolled in the study, and 440 were clinically and
microbiologically evaluable. The most common reasons patients were
nonevaluable were failure to return for specified visits and noncompliance
with the administration of the medication; 2 patients receiving penicillin
V discontinued use of the drug because of adverse events. INTERVENTION:
Patients were randomized to receive either 7-mg/kg cefdinir, 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 pyogenes and the clinical cure
of the signs and symptoms of pharyngitis, both determined 5 to 10 days
after the completion of therapy. RESULTS: Streptococcus pyogenes was
eradicated in 201 (90%) of the 224 patients receiving cefdinir and 155
(72%) of the 216 patients receiving penicillin V (95% confidence interval
[CI], 10.7%-25.1%; P < .001). The clinical cure rates were 92% and 91%
in the groups receiving cefdinir and penicillin V, respectively (95% CI,
-4.5% to 6.1%; P = .80). Adverse events, regardless of the opinion of the
investigator about their relationship to the study medication, occurred in
12.5% of the patients receiving cefdinir and 13.6% of the patients
receiving penicillin V (P = .69). CONCLUSIONS: A 5-day regimen of cefdinir
eradicated a higher proportion of S pyogenes than a 10-day regimen of
penicillin V. No difference was noted between the regimens for clinical
outcomes or adverse event rates.
