Comparison of two empiric antibiotic regimen in late onset neonatal sepsis--a randomized controlled trial.
OBJECTIVE
To compare the effectiveness of two antibiotic regimens among neonates with late onset sepsis (LOS).


METHODS
This randomized controlled trial conducted in a tertiary care teaching hospital, South India, included 90 babies with LOS. Detailed history, examination and appropriate investigations were done for all the babies. Cloxacillin + Amikacin were administered to 40 and Cefotaxime + Gentamicin to 50 babies. Outcomes including mortality, complications and treatment failure were evaluated. Chi-square test was used for categorical variables and Student's unpaired t-test for continuous variables.


RESULTS
LOS had a male preponderance, and median time of onset was 13 days. Mortality was more among low birth weight babies irrespective of the antibiotics. Predominant bacteria isolated were coagulase-negative staphylococci (26.67%), Escherichia coli (13.33%) and Streptococcus pneumoniae (13.33%). Complications, mortality and cost were similar in both regimens.


CONCLUSIONS
There was no significant difference between the two antibiotic regimens with regard to outcome of LOS.
Department of Paediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605 006, India.
Suresh
S
Ramasamy
Niranjan
N
Biswal
Adhisivam
A
Bethou
Betsy
B
Mathai
D000583:Amikacin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001424:Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy*; D002439:Cefotaxime / Q000008:administration & dosage*; D003023:Cloxacillin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005839:Gentamicins / Q000008:administration & dosage* / Q000627:therapeutic use; D006784:Hospitals, Teaching; D006801:Humans; D007194:India / Q000453:epidemiology; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay; D008297:Male; D017063:Outcome Assessment, Health Care; D018805:Sepsis / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D016037:Single-Blind Method; D013997:Time Factors
D000900:Anti-Bacterial Agents; D005839:Gentamicins; D000583:Amikacin; D002439:Cefotaxime; D003023:Cloxacillin
antibiotics; late onset sepsis; neonate