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Improving Dosing of Vancomycin in Young Infants With Infections (VANCAPP)

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ClinicalTrials.gov Identifier: NCT04044703
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Royal Children's Hospital
Royal Hospital For Women
University of Otago
Information provided by (Responsible Party):
Amanda Wilkins, Murdoch Childrens Research Institute

Brief Summary:
Current dosing regimens for vancomycin result in many young infants not reaching the target level of vancomycin in the blood at steady state (when the blood is in equilibrium at 24-48 hours).The purpose of this study is to assess an improved method of calculating the dose of vancomycin ('model-based dosing') in young infants with infections in order for them to achieve the target vancomycin level at steady state. A dosing calculator (which will be available through a web application) will be used for the dose calculation.

Condition or disease Intervention/treatment Phase
Sepsis Infection Bacteremia Drug: Vancomycin - model-based dosing regimen Phase 4

Detailed Description:

Standard of care dosing of vancomycin in young infants is based on weight (eg. 15 mg/kg/dose). There is evidence that many young infants who are prescribed vancomycin using this calculation will not have enough vancomycin in the blood at steady state to treat an infection effectively. In this study a dosing calculator will be used to generate each participant's dose with the aim to improve the number of participant's who achieve the target vancomycin level (10 - 20 mg/L) at steady state. The dosing calculator is based on a pharmacokinetic/pharmacodynamic model of vancomycin which was built from prospective data. The participant's weight, post-menstrual age, creatinine and target vancomycin level will be entered into the dosing calculator (available on a web application), and the calculator will provide the dosing regimen for that participant. The participant will have the vancomycin level checked at 24-48 hours to assess if the target level has been achieved.

This study is 'part 1' of the study protocol (version 4.0) as approved under HREC reference number HREC/51942/RCHM‐2019. This protocol also includes a second study, 'part 2', which will be registered with clinicaltrials.gov separately. Part 2 will assess the use of early drug monitoring and early dose adjustment to achieve the target vancomycin level in the blood at steady state. Part 1 of this protocol will be completed before part 2 begins recruitment. Part 1 and part 2 are two separate studies and the results of each part will not be compared to one another. However, each part will be compared to a retrospective control arm - infants from the VANC randomized controlled trial (NCT02210169) who received standard intermittent infusion of vancomycin dosing (as per British National Formulary for children. 15mg/kg/dose) and standard therapeutic drug monitoring.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 1)
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Model-based vancomycin dosing
Participants will receive model-based intermittent intravenous vancomycin dosing as calculated by the dosing calculator available on a web application. Participants will then have routine therapeutic drug monitoring and linear dose adjustments.
Drug: Vancomycin - model-based dosing regimen
A dosing calculator based on a population pharmacokinetic model for vancomycin will be used to generate a participant's intermittent vancomycin dosing regimen. The participant's post-menstrual age, weight, creatinine and the target trough vancomycin level will be entered into the dosing calculator and the dose will be generated (intermittent infusion, dosing frequency will be from 1 to 4 times per day according to the corrected gestational age).




Primary Outcome Measures :
  1. The proportion of young infants achieving target trough vancomycin concentrations (10 to 20 mg/L) at the first steady-state level when using a model-based dosing regimen [ Time Frame: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose. ]

Secondary Outcome Measures :
  1. The proportion of young infants with supra- (defined as >20mg/L) or sub- (defined as <10mg/L) therapeutic vancomycin concentrations at the first steady state level using a model-based dosing regimen (through a web application) [ Time Frame: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose. ]
  2. The proportion of young infants who are excluded from the study due to the model-based dosing regimen providing a total daily dose which exceeds 80 mg/kg/day despite a target trough concentration of 10 mg/L. [ Time Frame: From consent to calculation of vancomycin dose (immediately after consent) ]
  3. The frequency of drug-related adverse events (including infusion-related adverse events and nephrotoxicity). [ Time Frame: From first vancomycin dose (immediately after consent) to completion of vancomycin therapy (as determined by clinical team, an average of 5 days) ]
  4. The frequency of drug administration errors [ Time Frame: From first vancomycin dose to completion of vancomycin therapy (as determined by clinical team, an average of 5 days) ]


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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants aged 0 - 90 days old
  • Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)
  • Post-Menstrual age (PMA) matched to PMA-group from retrospective control group

Exclusion Criteria:

  • Infants born at a gestational age of less than 25 weeks
  • Infants weighing less than 500g
  • Known allergy to any glycopeptide antibiotic
  • Vancomycin administered within the previous 72 hours
  • Infants receiving any form of extracorporeal life support
  • Renal impairment
  • Previously enrolled in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044703


Contacts
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Contact: Amanda Wilkins, MBBS 9345 5522 amanda.wilkins@rch.org.au

Locations
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Australia, New South Wales
Royal Hospital for Women Not yet recruiting
Sydney, New South Wales, Australia, 2031
Contact: Srinivas Bolisetty, MD    (02) 9382 6111    Srinivas.Bolisetty@health.nsw.gov.au   
Australia, Victoria
Royal Children's Hospital Melbourne Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Amanda Wilkins, MBBS    9345 5522    amanda.wilkins@rch.org.au   
Sponsors and Collaborators
Murdoch Childrens Research Institute
Royal Children's Hospital
Royal Hospital For Women
University of Otago
Investigators
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Principal Investigator: Amanda Wilkins, MBBS Murdoch Children's Research Institute

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Responsible Party: Amanda Wilkins, Paediatric trainee, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT04044703     History of Changes
Other Study ID Numbers: HREC2019.059
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Bacteremia
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents