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

Sponsors

Lead Sponsor: Hospital Italiano de Buenos Aires

Source Hospital Italiano de Buenos Aires
Brief 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.

Overall Status Completed
Start Date March 2007
Completion Date January 2011
Primary Completion Date August 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical outcome of infants Seven to ten days after starting antibiotics
Secondary Outcome
Measure Time Frame
Percentage of infants initially assigned to cefazolin group that were switched to vancomycin. Within 72 hours of starting treatment
Enrollment 109
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cefazolin

Arm Group Label: Cefazolin group

Intervention Type: Drug

Intervention Name: Vancomycin

Arm Group Label: Vancomycin

Intervention Type: Drug

Intervention Name: Amikacin

Eligibility

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.

Gender: All

Minimum Age: N/A

Maximum Age: 4 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jose M Cernadas, M.D. Principal Investigator Hospital Italiano de Buenos Aires
Location
Facility: Hospital Italiano de Buenos Aires
Location Countries

Argentina

Verification Date

May 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital Italiano de Buenos Aires

Investigator Full Name: Jose Ceriani Cernadas M.D.

Investigator Title: M.D.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cefazolin group

Type: Experimental

Description: Initial empirical treatment with cefazolin and amikacin

Label: Vancomycin

Type: Active Comparator

Description: Initial empirical treatment with vancomycin and amikacin

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov