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RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

Information source: Murdoch Childrens Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis; Infection; Bacteremia

Intervention: Continuous infusion of vancomycin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Murdoch Childrens Research Institute

Overall contact:
Amanda Gwee, MBBS, Phone: 9345 5522, Email: amanda.gwee@rch.org.au

Summary

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.

Clinical Details

Official title: A Randomised Controlled Trial of Continuous and Intermittent Infusion of Vancomycin in Neonates

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of neonates achieving target vancomycin concentrations in blood at steady state (48 hours)

Eligibility

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as

determined by the treating physician. Exclusion Criteria:

- Infants born at a 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 not other IV line is

available)

Locations and Contacts

Amanda Gwee, MBBS, Phone: 9345 5522, Email: amanda.gwee@rch.org.au

Mercy Hospital for Women, Melbourne, Victoria 3084, Australia; Not yet recruiting
Dan Casalaz, Email: DCasalaz@mercy.com.au

The Royal Children's Hospital, Melbourne, Victoria 3052, Australia; Recruiting
Amanda Gwee, Email: amanda.gwee@rch.org.au
Nigel Curtis, Principal Investigator
Noel Cranswick, Principal Investigator

Additional Information

Starting date: September 2014
Last updated: April 14, 2015

Page last updated: August 23, 2015

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