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Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Information source: Hospital Italiano de Buenos Aires
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nosocomial Neonatal Sepsis

Intervention: Cefazolin (Drug); Vancomycin (Drug); Amikacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hospital Italiano de Buenos Aires

Official(s) and/or principal investigator(s):
Jose M Cernadas, M.D., Principal Investigator, Affiliation: Hospital Italiano de Buenos Aires

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical outcome of infants

Secondary outcome: Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.

Eligibility

Minimum age: N/A. Maximum age: 4 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Newborn infants older than three days of life with suspected bacterial sepsis and

according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment. Exclusion Criteria:

- previous treatment with vancomycin during the week before,

- infants referred from other hospitals and, upon admission, were being treated with

antibiotics.

Locations and Contacts

Hospital Italiano de Buenos Aires, Buenos Aires, Capital 1181, Argentina
Additional Information

Starting date: March 2007
Last updated: May 31, 2013

Page last updated: August 23, 2015

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