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Obesity and antibiotics: study seeks safer dosing

NCT ID NCT06601257

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how to give the antibiotic vancomycin to obese adults. Researchers compared dosing based on weight versus kidney function to see which gives better drug levels. 35 healthy obese volunteers received a single dose and provided blood and urine samples. The goal is to improve safety and effectiveness of vancomycin in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vancomycin
What this could lead to
If successful, this could lead to better, safer dosing guidelines for vancomycin in people with obesity.
What could go wrong
This is a small, early-phase study with only 35 participants, so results may not apply to everyone. It focuses on drug levels, not direct treatment outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

35 people

The number who actually took part.

Started

Apr 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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) 2. Male or female adults age 18 to 50 years 3. Weight ≥ 80 kg 4. 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) Exclusion Criteria: 1. Pregnant or lactating females 2. Significant clinical illness within 3 weeks prior to screening 3. History of severe allergic diseases including drug allergies, with the exception of seasonal allergies 4. Patients initiated on GLP1 agonists 5. 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. 6. History of drug addiction or alcohol abuse within the past 12 months 7. Any clinically significant abnormal lab values (Chemistry and Complete Blood Count) during screening 8. Participants unwilling or unable to receive vancomycin by intravenous infusion 9. Individuals with a history of psychiatric or neurological illness, including seizure disorders 10. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg 11. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg 12. Pulse rate \<50 beats/minute or \>100 beats/minute. 13. History of hypersensitivity or infusion reaction to vancomycin, cetirizine, or famotidine 14. Participants with underlying hearing loss 15. Participants that are taking ototoxic drugs

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Conditions

The condition(s) this trial relates to.

Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pharmacokinetics and pharmacodynamics

Contacts and locations

Locations

  • Michigan Clinical Research Unit

    Ann Arbor, Michigan, 48108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.