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Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

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ClinicalTrials.gov Identifier: NCT01867138
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Jose Ceriani Cernadas M.D., Hospital Italiano de Buenos Aires

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 3, 2013
Last Update Posted Date June 3, 2013
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
Clinical outcome of infants [ Time Frame: Seven to ten days after starting antibiotics ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
Percentage of infants initially assigned to cefazolin group that were switched to vancomycin. [ Time Frame: Within 72 hours of starting treatment ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
Official Title  ICMJE Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nosocomial Neonatal Sepsis
Intervention  ICMJE
  • Drug: Cefazolin
  • Drug: Vancomycin
  • Drug: Amikacin
Study Arms  ICMJE
  • Experimental: Cefazolin group
    Initial empirical treatment with cefazolin and amikacin
    Interventions:
    • Drug: Cefazolin
    • Drug: Amikacin
  • Active Comparator: Vancomycin
    Initial empirical treatment with vancomycin and amikacin
    Interventions:
    • Drug: Vancomycin
    • Drug: Amikacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2013)
109
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01867138
Other Study ID Numbers  ICMJE 563
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose Ceriani Cernadas M.D., Hospital Italiano de Buenos Aires
Study Sponsor  ICMJE Hospital Italiano de Buenos Aires
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose M Cernadas, M.D. Hospital Italiano de Buenos Aires
PRS Account Hospital Italiano de Buenos Aires
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP