Ceftibuten vs. penicillin V in group A beta-hemolytic streptococcal pharyngitis. Members of the Ceftibuten Pharyngitis International Study Group
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M E Pichichero1, S E Mclinn, W M Gooch
1University of Rochester Medical Center, NY 14642, USA.
Insights
Once daily ceftibuten demonstrated superior efficacy and comparable safety to penicillin V for treating pediatric streptococcal pharyngitis and scarlet fever. This antibiotic offers a more effective treatment option for these common bacterial infections.
Area of Science:
- Pediatric infectious diseases
- Bacteriology
- Clinical pharmacology
Background:
- Group A beta-hemolytic streptococci (Streptococcus pyogenes) are common bacterial pathogens causing pharyngitis and scarlet fever in children.
- Penicillin V has been the standard treatment, but concerns about adherence and resistance necessitate evaluating alternative therapies.
Purpose of the Study:
- To compare the efficacy and safety of ceftibuten oral suspension with penicillin V in children diagnosed with streptococcal pharyngitis or scarlet fever.
Main Methods:
- Prospective, randomized, multicenter, investigator-blinded trial involving children aged 3-18 years.
- Patients received either ceftibuten (9 mg/kg once daily) or penicillin V (25 mg/kg/day in 3 divided doses) for 10 days.
- Clinical success and bacterial eradication were assessed 5-7 days post-therapy.
Main Results:
- Ceftibuten achieved higher clinical success rates (97% vs. 89%, P < 0.01) and bacterial eradication (91% vs. 80%, P < 0.01) compared to penicillin V.
- Both treatments showed similar safety profiles, with mild vomiting being the most common adverse event (2%).
- No cases of rheumatic fever or nephritis were reported in either group.
Conclusions:
- Once-daily ceftibuten is a safe and more effective alternative to thrice-daily penicillin V for treating group A streptococcal pharyngitis in children.
- The improved efficacy and convenient dosing schedule of ceftibuten may enhance treatment adherence and outcomes.
Abstract:
The efficacy and safety of a 10-day course of ceftibuten oral suspension (9 mg/kg once daily) were compared with those of penicillin V (25 mg/kg/day in 3 divided doses) in children 3 to 18 years old treated for symptomatic pharyngitis and scarlet fever caused by group A beta-hemolytic streptococci (Streptococcus pyogenes). The study was prospective, randomized, multicenter and investigator-blinded; patients were randomized in a 2:1 ratio (ceftibuten:penicillin V). Overall clinical success (cure/improvement) at the primary end point of treatment (5 to 7 days posttherapy) was achieved in 97% (285 of 294) of ceftibuten-treated patients vs. 89% (117 of 132) of penicillin V-treated patients (P < 0.01). Elimination of infecting streptococci 5 to 7 days posttherapy was achieved in 91% (267 of 294) of ceftibuten-treated patients vs 80% (105 of 132) of penicillin V-treated patients (P < 0.01). A significant rise in anti-streptolysin O or anti-DNase B was observed in approximately 30% of patients in both treatment groups. No patient developed rheumatic fever or nephritis. Treatment-related adverse events were similar between the two groups; mild vomiting (2%) was most frequently reported. These data suggest that once daily ceftibuten is as safe as and more effective than three times daily penicillin V for the treatment of group A beta-hemolytic streptococcal pharyngitis.