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A study of 5-day cefdinir treatment for streptococcal pharyngitis in children. Cefdinir Pediatric Pharyngitis Study
K J Tack1, J A Hedrick, E Rothstein
1Parke-Davis Pharmaceutical Research, Ann Arbor, Mich, USA.
Insights
A 5-day cefdinir regimen effectively eradicated Streptococcus pyogenes in children with pharyngitis, showing superior microbiological outcomes compared to a 10-day penicillin V regimen. Clinical cure and safety profiles were similar between the two treatments.
Area of Science:
- Pediatric infectious diseases
- Microbiology
- Pharmacology
Background:
- Streptococcal pharyngitis is a common childhood illness.
- Penicillin V is the standard treatment, typically requiring a 10-day course.
- Shorter antibiotic courses are desirable to improve compliance and reduce resistance.
Purpose of the Study:
- To compare the efficacy and safety of a 5-day cefdinir regimen versus a 10-day penicillin V regimen for treating streptococcal pharyngitis in children.
- To evaluate microbiological eradication and clinical cure rates.
- To assess the incidence of adverse events.
Main Methods:
- Investigator-blind, randomized controlled trial involving 440 children aged 1-12 years with confirmed Streptococcus pyogenes pharyngitis.
- Patients received either 7 mg/kg cefdinir twice daily for 5 days or 10 mg/kg penicillin V four times daily for 10 days.
- Outcomes assessed included S. pyogenes eradication and clinical cure 5-10 days post-therapy.
Main Results:
- S. pyogenes eradication was significantly higher with cefdinir (90%) compared to penicillin V (72%) (P < .001).
- Clinical cure rates were comparable: 92% for cefdinir and 91% for penicillin V (P = .80).
- Adverse event rates were similar between groups (12.5% for cefdinir vs. 13.6% for penicillin V, P = .69).
Conclusions:
- A 5-day course of cefdinir is more effective than a 10-day course of penicillin V in eradicating Streptococcus pyogenes in children with pharyngitis.
- Both regimens demonstrated similar clinical efficacy and safety profiles.
- Shorter cefdinir treatment offers a viable alternative for managing pediatric streptococcal pharyngitis.
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.