Comparative Study in Neonates with Septicemia Using Meropenem Versus Ceftriaxone Plus Vancomycin.

Abstract

ABSTRACT:BACKGROUND:Neonatal septicemia is an important cause of mortality in both developed and developing countries . The type and pattern of organisms that cause neonatal sepsis changes over time. In addition the causative organisms have developed increased drug resistance for the last two decades .OBJECTIVE:To compare the effectiveness and tolerability of two different antibiotic regimens in the initial treatment of suspected neonatal septicemia.PATIENTS AND METHODS:This is a controlled clinical trial on 80 neonates with a presumptive diagnosis of septicemia who were admitted to the children welfare teaching hospital of Baghdad from August 2010 to March 2011.Both early onset sepsis and late onset sepsis were included in this study. The diagnosis of probable sepsis was based on the presence of a repertoire of clinical symptoms and signs . Initial tests performed included complete blood count , CRP, and blood cultures. Neonates were randomly divided into two groups of forty neonates per each. The first group was given meropenem of 30mg/kg /dose every 12 hours , while the second group was treated by a combination of ceftriaxone 50mg/kg/dose every 12 hours plus vancomycin of 15mg/kg/dose every 12 hours. The duration of treatment was 7-14 days.RESULTS :The patients variables in the two treatment groups at entry were comparable. The most prevalent clinical features were reluctance to feed (83.75%), lethargy(70%) , pallor (47.5%), irritability (38.75%), and hypothermia(32.5%).Of the 80 neonates , 81.25% had positive CRP , 58.75% had abnormal WBC count(<5000 /mm3 or > 20000/mm3 ) , and 48.75% had positive blood culture for bacteria .Staphylococcus coagulase negative accounted for28.2% of the total isolates followed by E coli (23%) , Klebsiella pneumonia (20.5%), pseudomonas aeruginosa (17.9%), streptococcus (7.7%), and staphylococcus aureus (2.5%). The overall responses to treatment was significantly higher P<0.05 in the meropenem group with a cure rate of 87.5 % versus 67.5 % in vancomycin plus ceftriaxone . Neonates with early onset sepsis showed a significantly higher success rate (p<0.05) with meropenem than with ceftriaxone plus vancomycin (the cure rate 93.1% versus 60%)While there were no differences between the two treatment group regarding late onset sepsis 72.2 % versus 80 %.CONCLUSION:The most effective antibiotic for early onset sepsis in this study was meropenem, while it had equal effectiveness with the combination of ceftriaxone plus vancomycin against late onset sepsis.