Recruiting NCT07605806
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vancomycin (IV).
- Who it may be relevant to
- Registry conditions: Healthy Volunteer, Hypersensitivity Reactions, Vancomycin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin. The main question it aims to answer is: • Identifying novel biomarkers in blood that occur during infusion reaction Participants will: * Have allergy skin testing for vancomycin * Receive an infusion of vancomycin
Interventions
- Drug Vancomycin (IV)
single infusion of vancomycin in healthy volunteers
Primary outcome measures
- Serum vancomycin concentration (mg/mL) [Time frame: 30 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Johns Hopkins University School of Medicine — Baltimore
Identifiers
NCT: NCT07605806 · IRB00358755 · R21AI182531