RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

Murdoch Childrens Research Institute

Status: Completed

Conditions: Infection; Bacteremia; Sepsis

Treatments: Drug: Continuous infusion of vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02210169

Vanc_IIV vs CIV

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Intermittent infusion of vancomycin

No Intervention group

Description:

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

Continuous infusion of vancomycin

Active Comparator group

Description:

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

Treatment:

Drug: Continuous infusion of vancomycin