drugset / Trial / NCT01867138
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefazolin | Small molecule | — | — |
| Comparator | Vancomycin | Other / unclassified | — | — |
| Background | Amikacin | Small molecule | — | — |