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Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Primary Purpose

Nosocomial Neonatal Sepsis

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Cefazolin
Vancomycin
Amikacin
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nosocomial Neonatal Sepsis focused on measuring Coagulase negative staphylococcus, nosocomial neonatal sepsis, cefazolin, vancomycin, newborn

Eligibility Criteria

4 Days - 4 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cefazolin group

Vancomycin

Arm Description

Initial empirical treatment with cefazolin and amikacin

Initial empirical treatment with vancomycin and amikacin

Outcomes

Primary Outcome Measures

Clinical outcome of infants
Examination of each newborn infant by two of the investigators independently to establish whether the clinical outcome was adequate or inadequate. In order to achieve greater objectivity, the clinical examination was performed using the following criteria: Adequate: when the newborn infant had normal clinical parameters, a good general condition, appropriate tolerance to gastric feeding, normal temperature , negative blood and CSF cultures, and normalized results for the lab tests performed at the onset of the treatment. Inadequate: when one or more of the following were present: clinical course with persistence of any of the signs of sepsis, positive blood or CSF cultures after 72 hours from the onset of treatment, persistence of abnormal lab tests, and death by sepsis.

Secondary Outcome Measures

Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.
Patients with an inadequate 72 hour response to cefazolin were crossed over to receive vancomycin. The adjudication of response at 72 hours was delineated in a well-defined algorithm. To minimize bias, the final decision to switch treatments, initiated by the pediatrician in charge, required secondary review and agreement of another participating investigator as well as the attending NICU physician.

Full Information

First Posted
May 29, 2013
Last Updated
May 31, 2013
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT01867138
Brief Title
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Neonatal Sepsis
Keywords
Coagulase negative staphylococcus, nosocomial neonatal sepsis, cefazolin, vancomycin, newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefazolin group
Arm Type
Experimental
Arm Description
Initial empirical treatment with cefazolin and amikacin
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
Initial empirical treatment with vancomycin and amikacin
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Type
Drug
Intervention Name(s)
Amikacin
Primary Outcome Measure Information:
Title
Clinical outcome of infants
Description
Examination of each newborn infant by two of the investigators independently to establish whether the clinical outcome was adequate or inadequate. In order to achieve greater objectivity, the clinical examination was performed using the following criteria: Adequate: when the newborn infant had normal clinical parameters, a good general condition, appropriate tolerance to gastric feeding, normal temperature , negative blood and CSF cultures, and normalized results for the lab tests performed at the onset of the treatment. Inadequate: when one or more of the following were present: clinical course with persistence of any of the signs of sepsis, positive blood or CSF cultures after 72 hours from the onset of treatment, persistence of abnormal lab tests, and death by sepsis.
Time Frame
Seven to ten days after starting antibiotics
Secondary Outcome Measure Information:
Title
Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.
Description
Patients with an inadequate 72 hour response to cefazolin were crossed over to receive vancomycin. The adjudication of response at 72 hours was delineated in a well-defined algorithm. To minimize bias, the final decision to switch treatments, initiated by the pediatrician in charge, required secondary review and agreement of another participating investigator as well as the attending NICU physician.
Time Frame
Within 72 hours of starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Days
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Cernadas, M.D.
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
State/Province
Capital
ZIP/Postal Code
1181
Country
Argentina

12. IPD Sharing Statement

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Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

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