SepsisPhase 4VANCAPPNCT05770622
Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)
A Phase 4 study testing First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L) in people with Sepsis and Infections, run by Murdoch Childrens Research Institute at 4 sites in Australia.
Trial summary
A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. Read more about this study
- Who is it for?
- Ages 0 to 90 days
- Conditions the study is for
- Sepsis, Infections, Bacteremia
- What is being tested?
- First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesAustralia
- Study dates
- 10 Nov 2024to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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)
Who cannot join
- Infants with a 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Recruiting
Royal Children's Hospital Melbourne
Melbourne, Victoria, 3052
Amanda L Wilkins, MBBS, +61393455522, amanda.wilkins@rch.org.au
Amanda L Wilkins, MBBS
- Not yet recruiting
Monash Newborn
Melbourne
Atul Malhotra
- Not yet recruiting
Royal Hospital for Women
Sydney
Srinivas Bolisetty
- Recruiting
The Children's Hospital at Westmead
Sydney
Tony Lai
About this study
Official title: The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)
A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.
Read the detailed description
Therapeutic drug monitoring (TDM) for vancomycin is done once the drug is in steady state. In young infants, this occurs at 24-48hours after commencing vancomycin. If the concentration at steady state is not in therapeutic range (10-20 mg/L), the dose is adjusted and the concentration measured again 24 hour later. Using empiric vancomycin dosing regimens, fewer than 50% of infants achieve the target concentration at their first steady state level. Therefore once the dose is adjusted and concentration repeated, there is a delay of at least 48 hours before adequate antibiotic concentrations are achieved in the blood - delaying optimal treatment of life-threatening infections. This study aims to use early TDM and dose adjustment to improve the proportion of infants achieving target concentrations at their first steady-state level.
Using a published population pharmacokinetic model, we identified a linear relationship between the first-dose trough and steady-state trough (R2 = 0.51) as well as the first-dose trough and AUC24 at 48 hours (R2= 0.70). This suggests that TDM could be performed after the first dose and that this early trough level could be used to predict the steady state level, enabling earlier dose adjustment and thereby shortening the time to effective therapy. This model has therefore been used to develop an online 'First-dose trough dose adjustment calculator'.
In the VANC APP (Part 2)* study, participants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved.
*Note: This study is 'part 2' of the VANC APP study protocol as approved under HREC reference number HREC/51942/RCHM-2019. Part 1 was registered separately on clinicaltrials.gov (clinicaltrials.gov ID: NCT04044703). Part 1 has been completed and assessed the use of model-based individualised intermittent vancomycin dosing using the Vanc App dosing calculator in 40 young infants aged 0 to 90 days. The vancomycin concentration was measured at steady state (24-48 hours) to determine the proportion of infants achieving target concentrations. Part 1 and part 2 are two separate studies and the results of each part will not be directly compared to one another.
- Conditions
- Sepsis, Infections, Bacteremia
- Being tested
- First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)
- 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.
First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)Other
CALCULATOR: A 'First-dose trough dose adjustment calculator' was developed based on a population pharmacokinetic model. A participant's post-menstrual age, weight, creatinine, target trough concentration, dose, dosing interval and first-dose trough concentration (taken immediately before the second dose is due) are entered into the calculator. The calculator determines if a dose adjustment is required (based on whether the predicted steady-state trough concentration is <10mg/L or >20mg/L) and, if required, recommends a new adjusted dose.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin first-dose trough dose adjustment calculation | Experimental | Participants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. If the predicted steady-state level is within target range (10-20mg/L) the calculator will recommend continuing with the same dose. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved. Receives: Other: First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target concentration at first steady-state concentration
The proportion of young infants achieving target trough serum vancomycin concentrations (10 to 20 mg/L) at first steady-state level when model-based dosing is used followed by early therapeutic drug monitoring (and dose adjustment) after the first dose
Measured: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose
Secondary outcomes (2)
Sub- and supratherapeutic concentrations at first steady-state concentration
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 when model-based dosing is used followed by early therapeutic drug monitoring (and dose adjustment) after the first dose
Measured: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose
Drug-related adverse effects
The frequency of drug-related adverse effects (infusion-related 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start10 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital For Women, Sydney Children's Hospitals Network, Monash Health
- Responsible party
- Sponsor
- Investigators
- Amanda Wilkins, MBBS, Principal investigator, Royal Children's Hospital Melbourne, Murdoch Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770622
- Sponsor's protocol ID
- HREC2019.059 (part 2)
- Acronym
- VANCAPP
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2023
- Last updated
- 20 Apr 2026
- 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 20 Apr 2026. 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 2)
- ClinicalTrials.gov ID
- NCT05770622
- Acronym / sponsor ID
- VANCAPP / HREC2019.059 (part 2)
- Conditions
- Sepsis, Infections, Bacteremia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital For Women, Sydney Children's Hospitals Network, Monash Health
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Mar 2023 (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.
A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.
Detailed description
Therapeutic drug monitoring (TDM) for vancomycin is done once the drug is in steady state. In young infants, this occurs at 24-48hours after commencing vancomycin. If the concentration at steady state is not in therapeutic range (10-20 mg/L), the dose is adjusted and the concentration measured again 24 hour later. Using empiric vancomycin dosing regimens, fewer than 50% of infants achieve the target concentration at their first steady state level. Therefore once the dose is adjusted and concentration repeated, there is a delay of at least 48 hours before adequate antibiotic concentrations are achieved in the blood - delaying optimal treatment of life-threatening infections. This study aims to use early TDM and dose adjustment to improve the proportion of infants achieving target concentrations at their first steady-state level.
Using a published population pharmacokinetic model, we identified a linear relationship between the first-dose trough and steady-state trough (R2 = 0.51) as well as the first-dose trough and AUC24 at 48 hours (R2= 0.70). This suggests that TDM could be performed after the first dose and that this early trough level could be used to predict the steady state level, enabling earlier dose adjustment and thereby shortening the time to effective therapy. This model has therefore been used to develop an online 'First-dose trough dose adjustment calculator'.
In the VANC APP (Part 2)* study, participants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved.
*Note: This study is 'part 2' of the VANC APP study protocol as approved under HREC reference number HREC/51942/RCHM-2019. Part 1 was registered separately on clinicaltrials.gov (clinicaltrials.gov ID: NCT04044703). Part 1 has been completed and assessed the use of model-based individualised intermittent vancomycin dosing using the Vanc App dosing calculator in 40 young infants aged 0 to 90 days. The vancomycin concentration was measured at steady state (24-48 hours) to determine the proportion of infants achieving target concentrations. Part 1 and part 2 are two separate studies and the results of each part will not be directly compared to one another.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin first-dose trough dose adjustment calculation | Experimental | Other: First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)Participants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. If the predicted steady-state level is within target range (10-20mg/L) the calculator will recommend continuing with the same dose. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved. |
Who may qualify
- Ages
- 0 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants aged 0 - 90 days old
- Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)
Key exclusion criteria (6 listed)
- Infants with a 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 |
|---|---|---|
| First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)CALCULATOR: A 'First-dose trough dose adjustment calculator' was developed based on a population pharmacokinetic model. A participant's post-menstrual age, weight, creatinine, target trough concentration, dose, dosing interval and first-dose trough concentration (taken immediately before the second dose is due) are entered into the calculator. The calculator determines if a dose adjustment is required (based on whether the predicted steady-state trough concentration is <10mg/L or >20mg/L) and, if required, recommends a new adjusted dose. | Other | Vancomycin first-dose trough dose adjustment calculation |
Primary outcome
Target concentration at first steady-state concentration
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 achieving target trough serum vancomycin concentrations (10 to 20 mg/L) at first steady-state level when model-based dosing is used followed by early therapeutic drug monitoring (and dose adjustment) after the first dose
2 secondary outcomes
Sub- and supratherapeutic concentrations at first steady-state concentration
Time frame: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose
Drug-related adverse effects
Time frame: From first vancomycin dose (immediately after consent) to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- 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.
Amanda Wilkins, MBBS principal investigator
Royal Children's Hospital Melbourne, Murdoch Children's 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 First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L) in people with Sepsis and Infections, 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Wilkins, MBBS (9345 5522, amanda.wilkins@rch.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target concentration at first steady-state concentration (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 20 Apr 2026.