Scientists hunt for hidden clues to drug reactions in the blood
NCT ID NCT07605806
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study aims to find new markers in the blood that appear during non-allergic drug infusion reactions. Healthy adults will receive the antibiotic vancomycin and have blood samples taken to measure drug levels and other substances. The goal is to better understand and predict these reactions, not to treat a disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins University School of Medicine
RECRUITINGBaltimore, Maryland, 21287, United States
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