Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
|ClinicalTrials.gov Identifier: NCT01867138|
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : June 3, 2013
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Cefazolin group
Initial empirical treatment with cefazolin and amikacin
Active Comparator: Vancomycin
Initial empirical treatment with vancomycin and amikacin
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867138
|Hospital Italiano de Buenos Aires|
|Buenos Aires, Capital, Argentina, 1181|
|Principal Investigator:||Jose M Cernadas, M.D.||Hospital Italiano de Buenos Aires|