Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vancomycin (IV)
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov