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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

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.


Condition or disease Intervention/treatment Phase
Nosocomial Neonatal Sepsis Drug: Cefazolin Drug: Vancomycin Drug: Amikacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Cefazolin group
Initial empirical treatment with cefazolin and amikacin
Drug: Cefazolin
Drug: Amikacin
Active Comparator: Vancomycin
Initial empirical treatment with vancomycin and amikacin
Drug: Vancomycin
Drug: Amikacin



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867138


Locations
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Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Capital, Argentina, 1181
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Jose M Cernadas, M.D. Hospital Italiano de Buenos Aires

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Responsible Party: Jose Ceriani Cernadas M.D., M.D., Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01867138     History of Changes
Other Study ID Numbers: 563
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013
Keywords provided by Jose Ceriani Cernadas M.D., Hospital Italiano de Buenos Aires:
Coagulase negative staphylococcus
nosocomial neonatal sepsis
cefazolin
vancomycin
newborn
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Vancomycin
Cefazolin
Amikacin
Coagulase
Anti-Bacterial Agents
Anti-Infective Agents
Coagulants