Vancomycin for Allergies
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how vancomycin, administered through infusion, affects individuals without traditional allergy markers. Researchers aim to identify new blood markers that emerge during a reaction to the drug. The study targets generally healthy individuals who have never taken vancomycin and do not have certain medical conditions, such as allergies to similar drugs or ongoing infections. Participants will undergo a skin allergy test for vancomycin and receive a single infusion of the drug. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants an opportunity to contribute to groundbreaking research.
Do I need to stop taking my current medications for the trial?
You will need to stop taking antihistamines one week before joining the study and cannot take them during the trial. If you are using beta-blockers, immunomodulatory therapies, oral corticosteroids, or biologics, you may not be eligible to participate.
Is there any evidence suggesting that vancomycin is likely to be safe for humans?
Research has shown that vancomycin, an antibiotic, can cause different reactions in some people. In a large study, about 0.3% of patients reported an allergy or sensitivity to vancomycin. This means that out of over 4 million patients, only a small number experienced some kind of reaction.
The most common reaction is a vancomycin infusion reaction (VIR), occurring in 3.7% to 47% of people receiving the drug. VIR can cause symptoms like skin redness and itching. In rare cases, more serious reactions like anaphylaxis, a severe allergic reaction, have occurred, but these are less common.
Overall, most people do not have a true allergy to vancomycin. Many reactions are not caused by the immune system, so they are not typical allergies. While there are risks, these reactions can often be managed by slowing the infusion or providing supportive care.12345Why are researchers excited about this trial's treatment for allergies?
Vancomycin is unique because it is being explored as an unconventional treatment for allergies, which is different from the usual antihistamines and corticosteroids. Typically used as an antibiotic, vancomycin's potential lies in its ability to modulate the microbiome, which might influence allergic responses. Researchers are excited about this approach because it targets the underlying microbiological factors, offering a fresh perspective on allergy management.
What evidence suggests that vancomycin might be an effective treatment for allergies?
Research has shown that vancomycin can cause various unexpected allergic reactions, known as hypersensitivity reactions. These reactions may occur immediately or take time to appear, with about 42% of cases showing immediate signs. The most common reaction is the vancomycin infusion reaction (VIR), occurring in up to 47% of patients. However, many patients (about 86%) who exhibit symptoms do not have a true allergy, meaning their reactions are not immune system-related. This trial will involve a single infusion of vancomycin in healthy volunteers to study these reactions. Identifying specific biomarkers, detectable signs in the blood, during these reactions is crucial for understanding how and why they occur. This could help doctors determine who might experience these reactions and how to prevent them.12346
Who Is on the Research Team?
Melanie Dispenza, MD, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for adults who are either healthy or have a known allergy to folinic acid, and may have had reactions to vancomycin. Participants should not have conditions that would make the study unsafe for them.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Allergy Skin Testing
Participants undergo allergy skin testing for vancomycin
Treatment
Participants receive an infusion of vancomycin to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions
Follow-up
Participants are monitored for safety and effectiveness after the vancomycin infusion
What Are the Treatments Tested in This Trial?
Interventions
- Vancomycin
Trial Overview
The study tests how people react to an IV infusion of vancomycin and looks for new blood markers linked to immediate allergic-type reactions. All participants get skin testing and then receive vancomycin by IV.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
single infusion of vancomycin in healthy volunteers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Citations
Vancomycin Hypersensitivity Reactions Documented in ... - PMC
Vancomycin causes diverse adverse reactions, including common (e.g., RMS) and severe (e.g., DRESS) reactions entered as DAL free-text. Anaphylaxis comprised 6% ...
Vancomycin Hypersensitivity: It Is Not Always What It Seems
Of the 18,761 documented suspected vancomycin HSRs, 42% were determined likely immediate and 20% likely nonimmediate on the basis of signs and symptoms ...
3.
jhoponline.com
jhoponline.com/articles/vancomycin-infusion-reaction-a-clinical-and-therapeutic-overviewVancomycin Infusion Reaction: A Clinical and Therapeutic ...
VIR is the most common hypersensitivity reaction associated with vancomycin use.1 The incidence of VIR is estimated to be 3.7% to 47% in patients who receive ...
Vancomycin Infusion Reaction
Approximately 86% of patients in our review did not have a true vancomycin allergy, defined as immune-mediated or hypersensitivity reactions ...
Vancomycin Flushing Syndrome Mimicking an Allergic ...
Rapid recognition and cessation of the vancomycin infusion led to prompt resolution of symptoms. Clinicians should be aware that VFS is a common ...
6.
blog.unmc.edu
blog.unmc.edu/infectious-disease/2022/10/04/pharmtoexamtable-vancomycin-allergy-and-cross-reactivity-with-lipoglycopeptides/#PharmToExamTable: Vancomycin Allergy and Cross ...
Clinical cross-reactivity between glycopeptides remains controversial, with varied reports suggesting possible immunological cross-reactivity.
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