Nosocomial Neonatal Sepsis Clinical Trial
Official title:
Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to
vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial
sepsis probably caused by Coagulase-negative staphylococcus.
The investigators hypothesized that newborn infants with the presumptive diagnosis of
nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome
not inferior to that of those treated with vancomycin.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment