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Studying Biomarkers for Vancomycin Reactions

This study is looking for new ways to identify immediate reactions to the antibiotic vancomycin, which are not caused by typical allergies (non-IgE-mediated hypersensitivity reactions). Researchers want to find markers in your blood that appear during an infusion reaction. You might be able to join if you are at least 18 years old and have healthy kidneys. Women who can become pregnant must agree to use effective birth control. All participants will have an allergy skin test for vancomycin and then receive a single infusion of vancomycin. The study aims to enroll 25 healthy volunteers, but its current recruitment status is unclear.

Study design
This is an interventional study involving 25 healthy volunteers. It is not specified if it is randomized or blinded.
What's involved
You will have an allergy skin test for vancomycin and receive a single infusion of vancomycin. Your blood will be tested to measure vancomycin levels 30 minutes after the infusion.
Compensation
Not stated in the trial record.
Follow-up
Your serum vancomycin concentration will be measured at 30 minutes after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07605806

Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions

Recruiting
PHASE1Ages 18+Interventional
Johns Hopkins University
~25 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Vancomycin (IV)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum vancomycin concentration (mg/mL)
Measured over 30 minutes

Conditions

Healthy Volunteer
Hypersensitivity Reactions
Vancomycin

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Healthy VolunteersNon-IgE-mediated Hypersensitivity Reaction

NCT07605806

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins University School of Medicine

    Baltimore, Marylandno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Melanie Dispenza, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Jennifer Hoffmann
[email protected]
4109551318
Email the study team

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Eligibility criteria

Inclusion

Male or female age ≥ 18 years.
Adequate kidney function as defined by creatinine level within normal institutional limits at the participant's first visit.
Women of child bearing potential must agree to a reliable form of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent.
Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, participants must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking.

Exclusion

Participants who have previously received vancomycin in any formulation, including oral or intravenous.
History of allergic reactions to study drug or reactions attributed to compounds of similar chemical or biologic composition to vancomycin, including active product or excipients.
Concurrent use of medications thought to cause non-specific mast cell activation (e.g. opioids)
Baseline serum tryptase over 8.0 ng/mL and/or known mast cell disorder, including, but not limited to, mastocytosis, idiopathic mast cell activation syndrome, and hereditary alpha tryptasemia
Active infection or immunodeficiency
Unstable cardiovascular disease
Renal insufficiency
Current hearing deficit
Current use of beta-blockers
Use of immunomodulatory therapies or oral corticosteroids within the previous 1 month
Use of biologics in the previous 6 months, including omalizumab
Participants taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with responses during drug challenge

What this trial measures

  • Serum vancomycin concentration (mg/mL)30 minutes

    The concentration of vancomycin in serum (in mg/mL) associated with an infusion reaction