Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Hospital Italiano de Buenos Aires

Status and phase: Completed; Phase 3

Conditions: Nosocomial Neonatal Sepsis

Treatments: Drug: Cefazolin; Drug: Vancomycin; Drug: Amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01867138

563

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 4 days to 4 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Cefazolin group

Experimental group

Description:

Initial empirical treatment with cefazolin and amikacin

Treatment:

Drug: Cefazolin

Drug: Amikacin

Vancomycin

Active Comparator group

Description:

Initial empirical treatment with vancomycin and amikacin

Treatment:

Drug: Amikacin

Drug: Vancomycin