MedTrace Logo

Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

NCT01867138 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2013-06-03

No results posted yet for this study

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

DRUG

Cefazolin

DRUG

Vancomycin

DRUG

Amikacin

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • Jose M Cernadas, M.D. · Hospital Italiano de Buenos Aires

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-08-31
Completion
2011-01-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867138 on ClinicalTrials.gov