Pharmacokinetics and PharmacodynamicsPhase 1NCT06601257
Vancomycin Dose Optimization in Obesity
A Phase 1 study testing Vancomycin (IV) in people with Pharmacokinetics and Pharmacodynamics, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics and Pharmacodynamics
- What is being tested?
- Vancomycin (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 27 Apr 2026
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 24 healthy obese participants within three obese class groups; BMI 30-34.9 kg/m2 (n=8), BMI 35-39.9 kg/m2 (n=8), and BMI ≥ 40 kg/m2 (n=8)
- Male or female adults age 18 to 50 years
- Weight ≥ 80 kg
- Estimated creatinine clearance of 60 mL/min to 119 mL/min (n=12) or ≥ 120 mL/min (n=12) (based on the Cockcroft-Gault equation and dosing weight)
Who cannot join
- Pregnant or lactating females
- Significant clinical illness within 3 weeks prior to screening
- History of severe allergic diseases including drug allergies, with the exception of seasonal allergies
- Patients initiated on GLP1 agonists
- Any other factor, condition, or disease, including but not limited to cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the participant or impact the validity of the study results.
- History of drug addiction or alcohol abuse within the past 12 months
Show all 15Show fewer
- Any clinically significant abnormal lab values (Chemistry and Complete Blood Count) during screening
- Participants unwilling or unable to receive vancomycin by intravenous infusion
- Individuals with a history of psychiatric or neurological illness, including seizure disorders
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
- Pulse rate \<50 beats/minute or \>100 beats/minute.
- History of hypersensitivity or infusion reaction to vancomycin, cetirizine, or famotidine
- Participants with underlying hearing loss
- Participants that are taking ototoxic drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clinical Research Unit
Ann Arbor, Michigan, 48108
About this study
Official title: An Open-Label, Single-Dose, Pharmacokinetic Study of Vancomycin Dosed by Weight or Kidney Function in Adults With Obesity
The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are:
Does dosing vancomycin based on kidney function provide better drug exposure than dosing based on weight? What medical or safety issues arise when vancomycin is dosed according to weight versus kidney function? Participants will be randomized into two groups. One group will receive vancomycin doses based on their weight, while the other will receive doses based on their kidney function.
Read more
Participants will:
Receive a single dose of vancomycin based on either their weight or kidney function after pretreatment with antihistamines Provide blood and urine samples at specific times for pharmacokinetic analysis Undergo body composition measurements using DEXA scans and other methods Visit the clinic for physical exams, medical history, and laboratory tests
Read the detailed description
This prospective, dosing group-randomized, single-dose pharmacokinetic study aims to evaluate vancomycin dosing in healthy obese participants across three BMI and two kidney function categories. Twenty-four participants will be enrolled, stratified by BMI (30-34.9 kg/m², 35-39.9 kg/m², ≥40 kg/m²) and creatinine clearance using dosing weight (CLcr_dw 60-119 mL/min or ≥120 mL/min). Twenty-four participants will be randomized (1:1) into a standard of care vancomycin group (Control) or a kidney function based group (Test). The study will include physical exams, medical history, and laboratory evaluations. Vancomycin doses will be administered based on weight or kidney function after pretreatment with antihistamines. Pharmacokinetic data will be collected through blood and urine samples at specific time points. Body composition measurements will be performed using DEXA and through anthropometric methods. Serum cystatin C concentrations will also be measured. Data analysis will include fitting vancomycin concentration-time data using a 2-compartment linear model to estimate area under the curve (AUC). Group comparisons for AUC target attainment (400-600 h*mg/L) will be performed using Fisher's Exact Test. Additionally, the study will test if the investigators can reduce the standard two-sample method for AUC estimation to a single sample. Different models of estimated glomerular filtration rate (eGFR) will be compared as predictors of vancomycin clearance (CL). This study will provide insights into optimizing vancomycin dosing in obese individuals with varying kidney function, potentially improving therapeutic drug monitoring strategies.
- Conditions
- Pharmacokinetics and Pharmacodynamics
- Being tested
- Vancomycin (IV)
- Keywords
- obesity, pharmacokinetics, vancomycin, antibiotics, body composition, kidney function, renal
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin (IV)Drug
Vancomycin weight-based or kidney function-based dosing
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Weight-stratified dosing as the current standard of care Receives: Drug: Vancomycin (IV) |
| Test | Experimental | Kidney function stratified dosing Receives: Drug: Vancomycin (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of target attainment
Number of participants with a vancomycin area under the concentration-time curve that is between 400 h*mg/L and 600 h*mg/L after a single dose.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2025
- Primary completion27 Apr 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pharmacokinetics and PharmacodynamicsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manjunath Prakash Pai, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601257
- Sponsor's protocol ID
- HUM00256444
- Other IDs
- 75F40122C00147
- Status last verified
- May 2026
- First submitted
- 11 Sep 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pai MP. Antimicrobial Dosing in Specific Populations and Novel Clinical Methodologies: Kidney Function. Clin Pharmacol Ther. 2021 Apr;109(4):952-957. doi: 10.1002/cpt.2179. Epub 2021 Mar 3.
PubMed 33523498Pai MP. Antimicrobial Dosing in Specific Populations and Novel Clinical Methodologies: Obesity. Clin Pharmacol Ther. 2021 Apr;109(4):942-951. doi: 10.1002/cpt.2181. Epub 2021 Feb 28.
PubMed 33523485Pai MP, Derstine BA, Lichty M, Ross BE, Sullivan JA, Su GL, Wang SC. Relationships of Vancomycin Pharmacokinetics to Body Size and Composition Using a Novel Pharmacomorphomic Approach Based on Medical Imaging. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01402-17. doi: 10.1128/AAC.01402-17. Print 2017 Nov.
PubMed 28807918Crass RL, Dunn R, Hong J, Krop LC, Pai MP. Dosing vancomycin in the super obese: less is more. J Antimicrob Chemother. 2018 Nov 1;73(11):3081-3086. doi: 10.1093/jac/dky310.
PubMed 30203073Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.
PubMed 32191793
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Pharmacokinetic Study of Vancomycin Dosed by Weight or Kidney Function in Adults With Obesity
- ClinicalTrials.gov ID
- NCT06601257
- Acronym / sponsor ID
- HUM00256444
- Conditions
- Pharmacokinetics and Pharmacodynamics
- Keywords
- obesity, pharmacokinetics, vancomycin, antibiotics, body composition, kidney function, renal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 19 Sep 2024 (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 learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are:
Does dosing vancomycin based on kidney function provide better drug exposure than dosing based on weight? What medical or safety issues arise when vancomycin is dosed according to weight versus kidney function? Participants will be randomized into two groups. One group will receive vancomycin doses based on their weight, while the other will receive doses based on their kidney function.
Participants will:
Receive a single dose of vancomycin based on either their weight or kidney function after pretreatment with antihistamines Provide blood and urine samples at specific times for pharmacokinetic analysis Undergo body composition measurements using DEXA scans and other methods Visit the clinic for physical exams, medical history, and laboratory tests
Detailed description
This prospective, dosing group-randomized, single-dose pharmacokinetic study aims to evaluate vancomycin dosing in healthy obese participants across three BMI and two kidney function categories. Twenty-four participants will be enrolled, stratified by BMI (30-34.9 kg/m², 35-39.9 kg/m², ≥40 kg/m²) and creatinine clearance using dosing weight (CLcr_dw 60-119 mL/min or ≥120 mL/min). Twenty-four participants will be randomized (1:1) into a standard of care vancomycin group (Control) or a kidney function based group (Test). The study will include physical exams, medical history, and laboratory evaluations. Vancomycin doses will be administered based on weight or kidney function after pretreatment with antihistamines. Pharmacokinetic data will be collected through blood and urine samples at specific time points. Body composition measurements will be performed using DEXA and through anthropometric methods. Serum cystatin C concentrations will also be measured. Data analysis will include fitting vancomycin concentration-time data using a 2-compartment linear model to estimate area under the curve (AUC). Group comparisons for AUC target attainment (400-600 h*mg/L) will be performed using Fisher's Exact Test. Additionally, the study will test if the investigators can reduce the standard two-sample method for AUC estimation to a single sample. Different models of estimated glomerular filtration rate (eGFR) will be compared as predictors of vancomycin clearance (CL). This study will provide insights into optimizing vancomycin dosing in obese individuals with varying kidney function, potentially improving therapeutic drug monitoring strategies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Vancomycin (IV)Weight-stratified dosing as the current standard of care |
| Test | Experimental | Drug: Vancomycin (IV)Kidney function stratified dosing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 24 healthy obese participants within three obese class groups; BMI 30-34.9 kg/m2 (n=8), BMI 35-39.9 kg/m2 (n=8), and BMI ≥ 40 kg/m2 (n=8)
- Male or female adults age 18 to 50 years
- Weight ≥ 80 kg
- Estimated creatinine clearance of 60 mL/min to 119 mL/min (n=12) or ≥ 120 mL/min (n=12) (based on the Cockcroft-Gault equation and dosing weight)
Key exclusion criteria (15 listed)
- Pregnant or lactating females
- Significant clinical illness within 3 weeks prior to screening
- History of severe allergic diseases including drug allergies, with the exception of seasonal allergies
- Patients initiated on GLP1 agonists
- Any other factor, condition, or disease, including but not limited to cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the participant or impact the validity of the study results.
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 (IV)Vancomycin weight-based or kidney function-based dosing | Drug | Control, Test |
Primary outcome
Probability of target attainment
Time frame: 24 hours
Number of participants with a vancomycin area under the concentration-time curve that is between 400 h*mg/L and 600 h*mg/L after a single dose.
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 22 May 2026.
- Background: PubMed 33523498Pai MP. Antimicrobial Dosing in Specific Populations and Novel Clinical Methodologies: Kidney Function. Clin Pharmacol Ther. 2021 Apr;109(4):952-957. doi: 10.1002/cpt.2179. Epub 2021 Mar 3.
- Background: PubMed 33523485Pai MP. Antimicrobial Dosing in Specific Populations and Novel Clinical Methodologies: Obesity. Clin Pharmacol Ther. 2021 Apr;109(4):942-951. doi: 10.1002/cpt.2181. Epub 2021 Feb 28.
- Background: PubMed 28807918Pai MP, Derstine BA, Lichty M, Ross BE, Sullivan JA, Su GL, Wang SC. Relationships of Vancomycin Pharmacokinetics to Body Size and Composition Using a Novel Pharmacomorphomic Approach Based on Medical Imaging. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01402-17. doi: 10.1128/AAC.01402-17. Print 2017 Nov.
- Background: PubMed 30203073Crass RL, Dunn R, Hong J, Krop LC, Pai MP. Dosing vancomycin in the super obese: less is more. J Antimicrob Chemother. 2018 Nov 1;73(11):3081-3086. doi: 10.1093/jac/dky310.
- Background: PubMed 32191793Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vancomycin (IV) in people with Pharmacokinetics and Pharmacodynamics, run by University of Michigan 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 4 inclusion and 15 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 22 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?
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?
Probability of target attainment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06601257, which also lists 5 linked publications.
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 22 May 2026.