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

被引:109
作者
Dagan, R
Hoberman, A
Johnson, C
Leibovitz, EL
Arguedas, A
Rose, FV
Wynne, BR
Jacobs, MR
机构
[1] Soroka Univ, Ctr Med, Pediat Infect Dis Unit, IL-84101 Beer Sheva, Israel
[2] Ben Gurion Univ Negev, Fac Hlth Sci, Beer Sheva, Israel
[3] Childrens Hosp Pittsburgh, Pittsburgh, PA 15213 USA
[4] Univ Colorado, Sch Med, Denver, CO USA
[5] Childrens Hosp, Denver, CO 80218 USA
[6] Inst Costarricense Invest Clinicas, San Jose, Costa Rica
[7] SmithKline Beecham Pharmaceut, Collegeville, PA USA
[8] Case Western Reserve Univ, Sch Med, Cleveland, OH USA
关键词
acute otitis media; high dose amoxicillin/clavulanate; bacteriologic efficacy; repeat tympanocentesis; Streptococcus pneumoniae; penicillin-resistant Streptococcus pneumoniae;
D O I
10.1097/00006454-200109000-00002
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Objectives. To determine the bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial pathogens causing acute otitis media (AOM), including penicillin-resistant Streptococcus pneumoniae (PRSP). Methods. In this open label multicenter study, 521 infants and children with 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 days. 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 before the first dose and repeated on Days 4 to 6 for all children with S. pneumoniae at 22 centers and for all children with any pathogen at 3 centers. Clinical response was assessed at end of therapy. Results. Pathogens were isolated from 355 (68%) of 521 enrolled children; 180 children underwent repeat tympanocentesis and were bacteriologically evaluable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacteriologically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bacteriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicillin MICs 2 to 4 mug/ml). Seventy-eight (94%) of 83 isolates of H. influenzae were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinically evaluable children with bacteriologically documented AOM. Conclusions. On the basis of bacteriologic outcome on Days 4 to 6 and clinical outcome on Days 12 to 15, we found that high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) was highly efficacious in children with AOM, including those most likely to fail treatment, namely children < 24 months of age and those with infections caused by PRSP.
引用
收藏
页码:829 / 837
页数:9
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