Ceftibuten vs. penicillin V in group A beta-hemolytic streptococcal pharyngitis. Members of the Ceftibuten Pharyngitis International Study Group.
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.
Pichichero
M E
ME
University of Rochester Medical Center, NY 14642, USA.
Mclinn
S E
SE
Gooch
W M
WM
Rodriguez
W
W
Goldfarb
J
J
Reidenberg
B E
BE
D000293:Adolescent; D000077722:Ceftibuten; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D004269:DNA, Bacterial / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010404:Penicillin V / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010612:Pharyngitis / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D012541:Scarlet Fever / Q000188:drug therapy*; D013290:Streptococcal Infections / Q000188:drug therapy*; D013297:Streptococcus pyogenes / Q000302:isolation & purification; D013535:Suspensions; D016896:Treatment Outcome
D002511:Cephalosporins; D004269:DNA, Bacterial; D010406:Penicillins; D013535:Suspensions; D000077722:Ceftibuten; D010404:Penicillin V