Comparison of ampicillin plus gentamicin vs. penicillin plus gentamicin in empiric treatment of neonates at risk of early onset sepsis

被引:39
作者
Metsvaht, T. [1 ]
Ilmoja, M-L [2 ]
Parm, Ue [3 ]
Maipuu, L. [1 ]
Merila, M. [4 ]
Lutsar, I. [3 ]
机构
[1] Tartu Univ Clin, Paediat Intens Care Unit, Clin Anaesthesiol & Intens Care, EE-51014 Tartu, Estonia
[2] Tallinn Childrens Hosp, Paediat Intens Care Unit, Tallinn, Estonia
[3] Univ Tartu, Inst Microbiol, EE-50090 Tartu, Estonia
[4] Tartu Univ Clin, Dept Paediat, EE-51014 Tartu, Estonia
关键词
Ampicillin; Antibiotic; Early onset; Neonatal sepsis; Penicillin; INFANTS; COLONIZATION; INFECTIONS; CEFOTAXIME; RESISTANCE; EMERGENCE; STRAINS; HEALTH; ERA;
D O I
10.1111/j.1651-2227.2010.01687.x
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
Aim: We aimed to compare the clinical efficacy of ampicillin (AMP) vs. penicillin (PEN) both combined with gentamicin in the empirical treatment of neonates at risk of early onset neonatal sepsis (EOS). Methods: We performed an open label cluster randomized equivalence study in both Estonian neonatal intensive care units, including neonates with suspected EOS, aged less than 72 h. Primary end-point was clinical failure rate, expressed by need for change of antibiotic regimen within 72 h and/or 7-day all cause mortality. Bowel colonization was followed with biweekly perineal swab cultures. Results: Incidence of proven EOS was 4.9%. Among neonates receiving AMP (n = 142) or PEN (n = 141) change of antibiotic regimen within 72 h (10/142 vs. 10/141; OR 1.02; 95% CI 0.40-2.59), 7-day mortality (11/142 vs. 14/141; OR 0.76; 95% CI 0.33-1.75) and over-all treatment failure (20/142 vs. 20/141; OR 1.01; 95% CI 0.52-1.97) occurred at similar rates. The only differences in gut colonization were lower number of patients colonised with enterococci, S. aureus and AMP resistant Acinetobacter spp. in AMP and lower number of those with S. haemolyticus and S. hominis in PEN arm. Conclusions: AMP and PEN combined with gentamicin have similar effectiveness in the empiric treatment of suspected neonatal EOS.
引用
收藏
页码:665 / 672
页数:8
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