drugset / Trial / NCT01867138

Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

NCT01867138

Phase 3 Completed 109 enrolled Hospital Italiano de Buenos Aires
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2007-03
Primary completion
2010-08
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefazolin Small molecule
Comparator Vancomycin Other / unclassified
Background Amikacin Small molecule

Indications