Actively Recruiting
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Led by Johns Hopkins University · Updated on 2026-05-26
25
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying biomarkers related to non-IgE immediate hypersensitivity reactions during intravenous vancomycin infusion. The trial aims to identify new blood biomarkers that appear during infusion reactions to better understand these allergic responses. This study is being conducted in healthy volunteers and sponsored by Johns Hopkins University. Participants will receive a single infusion of vancomycin and undergo allergy skin testing for vancomycin. The trial includes a single treatment arm involving this infusion administered under medical supervision. The primary outcome is measuring serum vancomycin concentration 30 minutes after infusion. During the study, participants will be monitored for allergic reactions and have blood samples taken to identify biomarkers. Researchers will also evaluate kidney function and other safety measures. The total participation time varies with the infusion and observation periods, with careful follow-up during and after the infusion to monitor any hypersensitivity events.
CONDITIONS
Brief Title
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 63 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 prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy.
- 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.
You will not qualify if you...
- Participants who have previously received vancomycin in any formulation.
- History of allergic reactions to vancomycin or related compounds.
- 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.
- 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 refrain from taking them during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive a single infusion of vancomycin.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
J
Jennifer Hoffmann
P
Pooja Akoijam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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