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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02210169




Registration number
NCT02210169
Ethics application status
Date submitted
5/08/2014
Date registered
6/08/2014
Date last updated
2/11/2018

Titles & IDs
Public title
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
Scientific title
A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates
Secondary ID [1] 0 0
Vanc_IIV vs CIV
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Infection 0 0
Bacteremia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Continuous infusion of vancomycin

No Intervention: 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.

Active Comparator: 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.


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Drug-related adverse effects
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Time to achieve target levels
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Clearance of vancomycin in young infants
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Volume of distribution of vancomycin in young infants
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Area under the concentration-time curve of vancomycin in young infants
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Timepoint [6] 0 0
2 years

Eligibility
Key inclusion criteria
- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as
determined by the treating physician.
Minimum age
No limit
Maximum age
90 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Hospital for Women - Sydney
Recruitment hospital [2] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Hospital For Women
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02210169
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Gwee, MBBS
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries