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

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.

Study Overview

• Status: Completed
• Conditions: Nosocomial Neonatal Sepsis
• Intervention / Treatment: Drug: Vancomycin; Drug: Cefazolin; Drug: Amikacin

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Capital
    • Buenos Aires, Capital, Argentina, 1181
      • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 days to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Seven to ten days after starting antibiotics

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 72 hours of starting treatment

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Investigators: Principal Investigator: Jose M Cernadas, M.D., Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 3, 2013

Study Record Updates

• Last Update Posted (Estimate): June 3, 2013
• Last Update Submitted That Met QC Criteria: May 31, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: vancomycin; newborn; cefazolin; Coagulase negative staphylococcus; nosocomial neonatal sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Cefazolin; Amikacin
• Other Study ID Numbers: 563