SepsisPhase 1VAST-iNCT07084129
Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
A Phase 1 study testing personalized dosing adjustment of vancomycin in people with Sepsis, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Sepsis
- What is being tested?
- personalized dosing adjustment of vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 31 May 2027
- Phase
- Phase 1
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age >1 month and <18 years
- Weight >5kg and <50kg
- Vancomycin intended duration of therapy ≥48 hours
- Admitted to intensive care unit with suspected or confirmed sepsis
- Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment)
Who cannot join
- Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
- Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)>1
- Central nervous system infection
- Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
- Pregnancy
- Patients on chronic dialysis therapy
- Patients with known history of delayed vancomycin clearance based on local pharmacy records
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Alanah McKelvey, 215-590-1000, mckelveya@chop.edu
Julie Fitzgerald, MD PhD
About this study
Official title: Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention
The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are:
- Is it feasible to use personalized models of vancomycin dosing in children with sepsis?
- Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?
- Conditions
- Sepsis
- Being tested
- personalized dosing adjustment of vancomycin
- Keywords
- sepsis, vancomycin, biomarker, pharmacokinetics
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized dosing adjustment of vancomycinOther
A personalized vancomycin PK model that incorporates kidney injury biomarkers will be used for vancomycin dose adjustments to achieve goal AUC levels.
| Study group | Role | What they receive |
|---|---|---|
| Personalized vancomycin Pharmacokinetic model for dose adjustments | Experimental | Enrolled patients who are prescribed vancomycin by the clinical team will transition to the study-determined empiric vancomycin dosing at the time of enrollment, 12mg/kg/dose administered as an extended intravenous (IV) infusion over 2 hours given every 6 hours. Urinary neutrophil gelatinase-associated lipocalin (NGAL) will be measured as soon as possible after enrollment. Dosage adjustments will be made using the personalized vancomycin pharmacokinetic (PK) model incorporating the NGAL level once resulted. Daily urinary NGAL will be measured while on vancomycin therapy and in the intensive care unit (ICU) to evaluate for ongoing changes in renal function that may necessitate further dosage adjustments using the personalized vancomycin PK model, until clinically stabilized. Patients will undergo vancomycin area under the curve (AUC) monitoring with three timed blood draws for vancomycin concentrations with each vancomycin dosing change with a goal AUC target range of 400-600. Receives: Other: personalized dosing adjustment of vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - personalized dose adjustment performed
Percentage of enrolled patients in which urinary neutrophil gelatinase-associated lipocalin is measured and used to make a vancomycin dosing recommendation
Measured: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Secondary outcomes (8)
Feasibility - Use of study-determined empiric vancomycin dosing
Percentage of patients transitioned to the study-determined empiric vancomycin dosing.
Measured: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Feasibility - Area under the curve sampling attainment on study empiric vancomycin dosing
Percentage of patients transitioned to the study-determined empiric vancomycin dosing and undergo subsequent area under the curve sampling.
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Feasibility - Dosing change based on urinary neutrophil gelatinase-associated lipocalin level
Percentage of patients enrolled in which urinary neutrophil gelatinase-associated lipocalin is used to make a dosing recommendation and results in administration of at least one adjusted dose of vancomycin.
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Feasibility - Area under the curve sampling attainment after personalized dose adjustment
Percentage of patients who undergo dose adjustment and have subsequent area under the curve sampling performed
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - area under the curve in goal range
Percentage of patients achieving area under the curve in goal range of 400-600mg-h/L.
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - resolution of gram positive infection
Percentage of patients with resolution of gram positive infection within the standard antibiotic duration for the infectious etiology.
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - development of acute kidney injury
Percentage of patients who develop acute kidney injury during the intervention.
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - treatment failure
Percentage of patients with treatment failure.
Measured: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Apr 2026
- Primary completion15 May 2027 (estimated)
- Study completion31 May 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 Children's Hospital of PhiladelphiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084129
- Sponsor's protocol ID
- 24-022663
- Other IDs
- K23DK119463
- Acronym
- VAST-i
- Status last verified
- May 2026
- First submitted
- 17 Jul 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention
- ClinicalTrials.gov ID
- NCT07084129
- Acronym / sponsor ID
- VAST-i / 24-022663
- Conditions
- Sepsis
- Keywords
- sepsis, vancomycin, biomarker, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Jul 2025 (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.
The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are:
- Is it feasible to use personalized models of vancomycin dosing in children with sepsis?
- Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized vancomycin Pharmacokinetic model for dose adjustments | Experimental | Other: personalized dosing adjustment of vancomycinEnrolled patients who are prescribed vancomycin by the clinical team will transition to the study-determined empiric vancomycin dosing at the time of enrollment, 12mg/kg/dose administered as an extended intravenous (IV) infusion over 2 hours given every 6 hours. Urinary neutrophil gelatinase-associated lipocalin (NGAL) will be measured as soon as possible after enrollment. Dosage adjustments will be made using the personalized vancomycin pharmacokinetic (PK) model incorporating the NGAL level once resulted. Daily urinary NGAL will be measured while on vancomycin therapy and in the intensive care unit (ICU) to evaluate for ongoing changes in renal function that may necessitate further dosage adjustments using the personalized vancomycin PK model, until clinically stabilized. Patients will undergo vancomycin area under the curve (AUC) monitoring with three timed blood draws for vancomycin concentrations with each vancomycin dosing change with a goal AUC target range of 400-600. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age >1 month and <18 years
- Weight >5kg and <50kg
- Vancomycin intended duration of therapy ≥48 hours
- Admitted to intensive care unit with suspected or confirmed sepsis
- Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment)
Key exclusion criteria (7 listed)
- Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
- Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)>1
- Central nervous system infection
- Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
- Pregnancy
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 |
|---|---|---|
| personalized dosing adjustment of vancomycinA personalized vancomycin PK model that incorporates kidney injury biomarkers will be used for vancomycin dose adjustments to achieve goal AUC levels. | Other | Personalized vancomycin Pharmacokinetic model for dose adjustments |
Primary outcome
Feasibility - personalized dose adjustment performed
Time frame: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Percentage of enrolled patients in which urinary neutrophil gelatinase-associated lipocalin is measured and used to make a vancomycin dosing recommendation
8 secondary outcomes
Feasibility - Use of study-determined empiric vancomycin dosing
Time frame: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Feasibility - Area under the curve sampling attainment on study empiric vancomycin dosing
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Feasibility - Dosing change based on urinary neutrophil gelatinase-associated lipocalin level
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Feasibility - Area under the curve sampling attainment after personalized dose adjustment
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - area under the curve in goal range
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - resolution of gram positive infection
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - development of acute kidney injury
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Efficacy and safety - treatment failure
Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
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 18 May 2026.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing personalized dosing adjustment of vancomycin in people with Sepsis, run by Children's Hospital of Philadelphia at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Julie Fitzgerald, MD PhD (215-590-4879, fitzgeraldj@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - personalized dose adjustment performed (time frame: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment). 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 18 May 2026.