Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children.
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.
Casellas
Javier María
JM
Pediatric Infectious Diseases, Hospital de Niños de San Isidro, French 3085, 1425 Buenos Aires, Argentina. javier_casellas@yahoo.com.ar
Israele
Víctor
V
Marín
Marcelo
M
Ishida
María T
MT
Heguilen
Ricardo
R
Soutric
Jorge
J
Arenoso
Héctor
H
Sibbald
Andrés
A
Stamboulian
Daniel
D
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
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D013407:Sulbactam