Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media

Citation
R. Dagan et al., Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media, PEDIAT INF, 20(9), 2001, pp. 829-837
Citations number
32
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Clinical Immunolgy & Infectious Disease
Journal title
PEDIATRIC INFECTIOUS DISEASE JOURNAL
ISSN journal
0891-3668 → ACNP
Volume
20
Issue
9
Year of publication
2001
Pages
829 - 837
Database
ISI
SICI code
0891-3668(200109)20:9<829:BACEOH>2.0.ZU;2-7
Abstract
Objectives. To determine the bacteriologic and clinical efficacy of high do se amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial path ogens causing acute otitis media (AOM), including penicillin-resistant Stre ptococcus pneumoniae (PRSP). Methods. In this open label multicenter study, 521 infants and children wit h AOM [mean age, 18.6 months; age < 24 months, n = 375 (72%)] were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 d ays. Bilateral otitis media, previous episodes of AOM, antibiotic treatment within 3 months and day-care attendance were recorded in 60.1, 35.7, 50.2 and 38.2% of the children, respectively. Tympanocentesis was performed befo re the first dose and repeated on Days 4 to 6 for all children with S. pneu moniae at 22 centers and for all children with any pathogen at 3 centers. C linical response was assessed at end of therapy. Results. Pathogens were isolated from 355 (68%) of 521 enrolled children; 1 80 children underwent repeat tympanocentesis and were bacteriologically eva luable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacterio logically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bac teriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicil lin MICs 2 to 4 mug/ml). Seventy-eight (94%) of 83 isolates of H. influenza e were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinic ally evaluable children with bacteriologically documented AOM. Conclusions. On the basis of bacteriologic outcome on Days 4 to 6 and clini cal outcome on Days 12 to 15, we found that high dose amoxicillin/clavulana te (90/6.4 mg/kg/day) was highly efficacious in children with AOM, includin g those most likely to fail treatment, namely children < 24 months of age a nd those with infections caused by PRSP.