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Ceftibuten vs. penicillin V in group A beta-hemolytic streptococcal pharyngitis. Members of the Ceftibuten Pharyngitis International Study Group.

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.
AuthorsM E Pichichero, S E Mclinn, W M Gooch 3rd, W Rodriguez, J Goldfarb, B E Reidenberg
JournalThe Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 14 Issue 7 Suppl Pg. S102-7 (Jul 1995) ISSN: 0891-3668 [Print] United States
PMID7567309 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Cephalosporins
  • DNA, Bacterial
  • Penicillins
  • Suspensions
  • Ceftibuten
  • Penicillin V
Topics
  • Adolescent
  • Ceftibuten
  • Cephalosporins (administration & dosage, adverse effects, therapeutic use)
  • Child
  • Child, Preschool
  • Confidence Intervals
  • DNA, Bacterial (analysis)
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Penicillin V (administration & dosage, adverse effects, therapeutic use)
  • Penicillins (administration & dosage, adverse effects, therapeutic use)
  • Pharyngitis (drug therapy, microbiology)
  • Prospective Studies
  • Scarlet Fever (drug therapy)
  • Streptococcal Infections (drug therapy)
  • Streptococcus pyogenes (isolation & purification)
  • Suspensions
  • Treatment Outcome

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