Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

NCT01867138 | Completed Phase 3 DMC

• 1 other identifier: 563
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Nosocomial Neonatal Sepsis

Keywords

Coagulase negative staphylococcus; nosocomial neonatal sepsis; cefazolin; vancomycin; newborn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.

  Within 72 hours of starting treatment

Study Arms (2)

Cefazolin group

EXPERIMENTAL

Initial empirical treatment with cefazolin and amikacin

Drug: Cefazolin; Drug: Amikacin

Vancomycin

ACTIVE COMPARATOR

Initial empirical treatment with vancomycin and amikacin

Drug: Vancomycin; Drug: Amikacin

Interventions

Cefazolin DRUG

Cefazolin group

Vancomycin DRUG

Vancomycin

Amikacin DRUG

Cefazolin group; Vancomycin

Eligibility Criteria

• Age: 4 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• previous treatment with vancomycin during the week before,
• infants referred from other hospitals and, upon admission, were being treated with antibiotics.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Capital, 1181, Argentina

Location

MeSH Terms

Interventions

Cefazolin; Vancomycin; Amikacin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Kanamycin; Aminoglycosides; Glycosides

Study Officials

• Jose M Cernadas, M.D.

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: March 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2011
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

AR (1)