RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

Sepsis Clinical Trial

Official title:

A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210169
• Other study ID #: Vanc_IIV vs CIV
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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)

Related Conditions & MeSH terms

• Bacteremia
• Infection
• Sepsis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	The Royal Children's Hospital	Melbourne	Victoria
Australia	Royal Hospital for Women	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Royal Children's Hospital, Royal Hospital For Women

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)		2 years
Secondary	Drug-related adverse effects	the proportion of drug-related adverse effects with CIV compared to IIV	2 years
Secondary	Time to achieve target levels	the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood	2 years
Secondary	Clearance of vancomycin in young infants	Population pharmacokinetic modelling of vancomycin in young infants using NONMEM	2 years
Secondary	Volume of distribution of vancomycin in young infants	Population pharmacodynamics modelling of vancomycin in young infants using NONMEM	2 years
Secondary	Area under the concentration-time curve of vancomycin in young infants	Population pharmacodynamics modelling of vancomycin in young infants using NONMEM	2 years
Secondary	Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants	Population pharmacodynamics modelling of vancomycin in young infants using NONMEM	2 years