Open-Label, parallel-group, multicenter, randomized study of cefprozil versus erythromycin in children with group A
I Brook1, G H Aronovitz, M E Pichichero
1Department of Pediatrics, Georgetown University School of Medicine, Washington, DC 20016, USA.
Insights
Cefprozil demonstrated a higher bacterial eradication rate than erythromycin for treating pediatric Group A Streptococcus pharyngitis. Both antibiotics achieved similar clinical cure rates, with comparable tolerability profiles.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and therapeutics
- Microbiology
Background:
- Group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis often requires antibiotic treatment.
- Cefprozil and erythromycin serve as alternative therapies to penicillin for GABHS infections.
Purpose of the Study:
- To compare the efficacy and tolerability of cefprozil versus erythromycin in treating pediatric GABHS pharyngitis/tonsillitis.
- To evaluate bacteriologic and clinical outcomes, as well as adverse events.
Main Methods:
- A randomized trial involving children aged 2-12 with culture-documented GABHS pharyngitis/tonsillitis.
- Patients received 10 days of oral cefprozil or erythromycin suspension.
- Efficacy endpoints included bacteriologic eradication and clinical cure rates post-treatment.
Main Results:
- Cefprozil achieved a significantly higher GABHS eradication rate (95%) compared to erythromycin (74%).
- Clinical cure rates were similar between cefprozil (90%) and erythromycin (91%).
- Adverse event incidence was comparable, with diarrhea and vomiting being most common.
Conclusions:
- Cefprozil offers superior bacteriologic eradication for pediatric GABHS pharyngitis/tonsillitis compared to erythromycin.
- Both antibiotics are effective in achieving clinical cure in over 90% of pediatric patients.
Background:
Cefprozil and erythromycin are acceptable alternatives to penicillin in the treatment of pharyngitis/tonsillitis due to group A beta-hemolytic streptococcus (GABHS).
Objective:
The purpose of this trial was to determine the relative efficacy and tolerability of cefprozil and erythromycin in the treatment of pediatric pharyngitis/tonsillitis due to GABHS.
Methods:
This trial compared the bacteriologic and clinical efficacy of erythromycin and cefprozil in children 2 to 12 years of age with culture-documented GABHS pharyngitis/ tonsillitis. Children who were allergic to penicillin, cefprozil, or erythromycin were excluded. Patients were prospectively randomly assigned to receive 10 days of oral therapy with either cefprozil suspension 15 mg/kg per day in 2 divided doses or erythromycin ethylsuccinate suspension 30 mg/kg per day in 3 divided doses. Primary efficacy end points were bacteriologic and clinical response 2 to 8 days after treatment ended. The frequency and severity of adverse events and their relationship to treatment were also assessed.
Results:
A total of 199 patients were enrolled and treated (cefprozil, 99; erythromycin, 100); 12 patients in the cefprozil group and 15 in the erythromycin group were not evaluable. The GABHS eradication rate was significantly higher with cefprozil (95%) than with erythromycin (74%) (P = 0.001). The posttreatment carrier rate was lower in the cefprozil group (5%) than in the erythromycin group (18%) (95% CI, -22.3 to -3.8). Clinical cure rate was 90% (78/87) with cefprozil and 91% (77/85) with erythromycin (P = 0.95) (treatment group difference, -0.93; 95% CI, -9.9% to 8.0%). The overall incidence of drug-related adverse events was not significantly different in the 2 groups (11% with cef- prozil, 18% with erythromycin). The most common adverse events were diarrhea and vomiting. Two patients in the erythromycin group discontinued therapy because of adverse events.
Conclusions:
The bacteriologic eradication rate was significantly greater with cefprozil compared with erythromycin in children with pharyngitis/tonsillitis. Both cefprozil and erythromycin produced a clinical cure in >90% of patients.
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