NCT01867138

Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 4 Days – 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Nosocomial Neonatal Sepsis

Interventions

Type	Name	Description
DRUG	Cefazolin
DRUG	Vancomycin
DRUG	Amikacin

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-08-01
• Completion: 2011-01-01
• First posted: 2013-06-03
• Last updated: 2013-06-03

Locations

1 site across 1 country: Argentina