title: Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children.
abstract: Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6-48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80 mg/(kg day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120 Ax/S and 127 Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range < or = 0.016-1.0 and < or = 0.016-0.25 mg/L, respectively). Clinical efficacy at Days 12-14 and 28-42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.
authors.affiliation: Pediatric Infectious Diseases, Hospital de Niños de San Isidro, French 3085, 1425 Buenos Aires, Argentina. javier_casellas@yahoo.com.ar
authors.forename: Javier María
authors.initials: JM
authors.lastname: Casellas
authors.forename: Víctor
authors.initials: V
authors.lastname: Israele
authors.forename: Marcelo
authors.initials: M
authors.lastname: Marín
authors.forename: María T
authors.initials: MT
authors.lastname: Ishida
authors.forename: Ricardo
authors.initials: R
authors.lastname: Heguilen
authors.forename: Jorge
authors.initials: J
authors.lastname: Soutric
authors.forename: Héctor
authors.initials: H
authors.lastname: Arenoso
authors.forename: Andrés
authors.initials: A
authors.lastname: Sibbald
authors.forename: Daniel
authors.initials: D
authors.lastname: Stamboulian
mesh_terms: D000208:Acute Disease; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001118:Argentina; D002353:Carrier State / Q000188:drug therapy / Q000382:microbiology; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006192:Haemophilus Infections / Q000188:drug therapy; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D011008:Pneumococcal Infections / Q000188:drug therapy; D011446:Prospective Studies; D016037:Single-Blind Method; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D013407:Sulbactam / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D013407:Sulbactam