RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

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

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-05-31

Brief Summary

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Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.

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Detailed Description

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Conditions

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Sepsis Infection Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent infusion of vancomycin

Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.

Group Type NO_INTERVENTION

No interventions assigned to this group

Continuous infusion of vancomycin

A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.

Group Type ACTIVE_COMPARATOR

Continuous infusion of vancomycin

Intervention Type DRUG

Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.

Interventions

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Continuous infusion of vancomycin

Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.

Exclusion Criteria

* Infants with a corrected gestational age \< 25 weeks.
* Allergy to vancomycin or other glycopeptide antibiotic
* Vancomycin administered within the previous 72 hours
* Renal impairment
* Prior enrolment in the study
* Need for drug that is incompatible with vancomycin (if no other IV line is available)

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No