Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nosocomial Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cefazolin group

Initial empirical treatment with cefazolin and amikacin

Group Type EXPERIMENTAL

Cefazolin

Intervention Type DRUG

Amikacin

Intervention Type DRUG

Vancomycin

Initial empirical treatment with vancomycin and amikacin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Amikacin

Intervention Type DRUG

Interventions

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Cefazolin

Intervention Type DRUG

Vancomycin

Intervention Type DRUG

Amikacin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

4 Days

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No