SepsisPhase 4VANCAPPNCT04044703
Improving Dosing of Vancomycin in Young Infants With Infections
A Phase 4 study testing Vancomycin - model-based dosing regimen in people with Sepsis and Infection, run by Murdoch Childrens Research Institute at 4 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 90 days
- Conditions the study is for
- Sepsis, Infection, Bacteremia
- What is being tested?
- Vancomycin - model-based dosing regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesAustralia
- Study dates
- 30 Aug 2019to 3 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Infants with corrected 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Royal Children's Hospital Melbourne
Melbourne, Victoria, 3052
Monash Children's Hospital
Melbourne, Victoria
Royal Hospital for Women
Sydney, New South Wales, 2031
Children's Hospital at Westmead
Sydney, New South Wales
About this study
Official title: The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 1)
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.
Read the 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.
- Conditions
- Sepsis, Infection, Bacteremia
- Being tested
- Vancomycin - model-based dosing regimen
- Medical subject headings
- Sepsis, Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin - model-based dosing regimenDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Model-based vancomycin dosing | Experimental | 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. Receives: Drug: Vancomycin - model-based dosing regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose.
Secondary outcomes (4)
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)
Measured: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose.
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.
Measured: From consent to calculation of vancomycin dose (immediately after consent)
The frequency of drug-related adverse events (including infusion-related adverse events and nephrotoxicity).
Measured: From first vancomycin dose (immediately after consent) to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)
The frequency of drug administration errors
Measured: From first vancomycin dose to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start30 Aug 2019
- Primary completion29 Dec 2020
- Study completion3 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital For Women, University of Otago, Sydney Children's Hospitals Network, Monash Health
- Responsible party
- Principal investigator, Amanda Wilkins, Murdoch Childrens Research Institute
- Investigators
- Amanda Wilkins, MBBS, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044703
- Sponsor's protocol ID
- HREC2019.059
- Acronym
- VANCAPP
- Status last verified
- Aug 2021
- First submitted
- 31 Jul 2019
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 1)
- ClinicalTrials.gov ID
- NCT04044703
- Acronym / sponsor ID
- VANCAPP / HREC2019.059
- Conditions
- Sepsis, Infection, Bacteremia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital For Women, University of Otago, Sydney Children's Hospitals Network, Monash Health
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Model-based vancomycin dosing | Experimental | Drug: Vancomycin - model-based dosing regimenParticipants 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. |
Who may qualify
- Ages
- 0 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Infants with corrected 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin - model-based dosing regimenA 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). | Drug | Model-based vancomycin dosing |
Primary outcome
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.
4 secondary outcomes
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.
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Wilkins, MBBS principal investigator
Murdoch Childrens Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin - model-based dosing regimen in people with Sepsis and Infection, run by Murdoch Childrens Research Institute at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.