RECRUITING

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

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Conditions

Drug AllergyCephalosporin AllergyDrug HypersensitivityAntibiotic AllergyBeta Lactam Adverse ReactionDrug-Induced AnaphylaxisCephalosporin ReactionAllergyAntibioticCephalosporinPenicillinBeta-lactamDrug challengeSkin testingAdverse reactionAnaphylaxisPerioperative anaphylaxis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

Official Title

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Quick Facts

Study Start:2025-04-29
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06406114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-70 years old.
  2. 2. Reaction history consistent with a potential immediate hypersensitivity reaction (pruritus, urticaria, erythema, angioedema, bronchospasm, wheezing, shortness of breath, anaphylaxis, or hypotension) to cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime.
  3. 3. English speaking or non-English speaking with translation services available.
  1. 1. Severe concomitant medical condition (e.g., unstable coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, poorly controlled asthma, chronic renal failure, cirrhosis, or end-stage liver disease.)
  2. 2. History of Clostridioides difficile infection
  3. 3. Chronic spontaneous urticaria or systemic mastocytosis
  4. 4. Incident reaction required cardiopulmonary resuscitation
  5. 5. Reaction to 2 or more cephalosporin antibiotics
  6. 6. Active infection or antibiotic treatment within 7 days
  7. 7. Treatment with systemic antihistamines or corticosteroids within 7 days
  8. 8. Treatment with omalizumab or dupilumab within 60 days
  9. 9. Significant immunosuppression
  10. 10. Treatment with a beta-blocker or ACE inhibitor within 7 days
  11. 11. Use of investigational drugs within 60 days of participation
  12. 12. Anaphylaxis in the last 30 days
  13. 13. Penicillin anaphylaxis within the past year confirmed with positive penicillin skin tests
  14. 14. Prison or jail inmates, pregnant women, severe cognitive impairment
  15. 15. Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
  16. 16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
  17. 17. Inability or unwillingness of a participant to give written informed consent or comply with study protocol

Contacts and Locations

Study Contact

Liam R Smith, BS
CONTACT
6177242415
allergyresearch@mgh.harvard.edu
Ana D Fernandes, MA
CONTACT
6176432140
adfernandes@mgh.harvard.edu

Principal Investigator

Kimberly G Blumenthal, MD, MSc
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
David A Khan, MD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

Mayo Clinic Arizona
Scottsdale, Arizona, 14607
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Rochester General Hospital
Rochester, New York, 14621
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Kimberly G Blumenthal, MD, MSc, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
  • David A Khan, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Allergy
  • Antibiotic
  • Cephalosporin
  • Penicillin
  • Beta-lactam
  • Drug challenge
  • Skin testing
  • Adverse reaction
  • Anaphylaxis
  • Perioperative anaphylaxis

Additional Relevant MeSH Terms

  • Drug Allergy
  • Cephalosporin Allergy
  • Drug Hypersensitivity
  • Antibiotic Allergy
  • Beta Lactam Adverse Reaction
  • Drug-Induced Anaphylaxis
  • Cephalosporin Reaction