Optimizing the diagnostic approach to cephalosporin allergy testing (dacat trial)
Active Cooperative Agreement Awarded Last action
- Award ID
- U01AI184071
- Recipient
-
Mayo Clinic Jacksonville (A Nonprofit Corporation) UEI GKPBCFV1QMM3
- Awarding agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $18,388,922
Award facts
- Assistance listing
- 93.855 Allergy and Infectious Diseases Research
- Completion date 48% complete
- Place of performance
- Jacksonville, FL 32224, USA
Award details come from USAspending.gov.
Description
- Abstract
- In the united states, beta-lactam antibiotics are the leading cause of allergic reactions. Cephalosporin antibiotics, in particular, are the most common cause of drug-induced anaphylaxis and perioperative allergy. For penicillin allergy, the mechanism of allergy and the antigenic determinants are known; validated penicillin skin testing followed by drug challenge has a 100% negative predictive value to exclude an immunoglobulin (IG)e-mediated reaction. For cephalosporin allergy, the antigenic determinants and mechanism are not known, and skin testing is not validated. The diagnostic test characteristics of skin testing with native cephalosporins remain unclear with no sensitivity nor specificity reported. Although beta-lactam cross-reactivity has been hypothesized to be from the similarity of the R1 side chains, rather than the beta-lactam ring, cross-reactivity estimates among beta-lactams vary. Furthermore, IT is not known whether the variance in cross-reactivity is due to true allergy versus sensitization based on positive skin testing, given that drug challenges were not performed on skin-test-positive patients. While an IGE mechanism is assumed for cephalosporin allergy and supported by skin testing that has been positive, the biology has yet to be characterized, and some cephalosporin anaphylaxis can occur on the first exposure, which is inconsistent with an IGE mechanism. Given the complexity of cephalosporin structures and potential epitopes, there may be several distinct biologic pathways involved in cephalosporin allergy. Future diagnostics in cephalosporin allergy are reliant on determination of these biological pathways and finding key haptens. Current national practice guidelines related to cephalosporin allergy assessment are considered conditional and based on low-quality evidence. Our overall goal is to identify the optimal diagnostic approach to cephalosporin allergy and determine beta-lactam cross-reactivity, while discovering the mechanism and antigenic determinants of cephalosporin allergy to advance future diagnostics. We will do this through a clinical trial that will generate empirical evidence through novel trial procedures, double-blind skin testing, and double- blind placebo-controlled drug challenges. Our specific aims are: 1) to determine the optimal approach to cephalosporin allergy evaluation; 2) to assess beta-lactam cross-reactivity in cephalosporin-allergic individuals; and 3) to investigate the antigenic determinants and mechanism of cephalosporin allergy. We will achieve these aims through collaboration with an established network of drug allergy specialists. Our study is the first clinical trial in drug allergy that investigates diagnostic strategies and mechanisms for a common and important antibiotic class. This project aligns with NIH/niaid goals to advance drug allergy research and PAR-21-083 to support high-risk clinical trials with mechanistic studies.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $2,832,926 | |
| Amendment | $2,832,926 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $1,017,955 | |
| Amendment | -$1,017,955 | |
| Amendment | -$1,017,955 | |
| Amendment | $1,017,955 | |
| Amendment | -$1,017,955 | |
| Amendment | $1,017,955 | |
| Amendment | $1,017,955 | |
| Amendment | -$1,017,955 | |
| Amendment | $3,283,701 | |
| Amendment | $3,283,701 | |
| Amendment | $313,404 | |
| Amendment | $2,921,132 | |
| Original award | $2,921,132 |
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Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| The Regents Of The University Of California. San Francisco | $131,200 | |
| Vanderbilt University Medical Center | $354,446 | |
| Brigham & Womens Hospital Inc. | $340,158 | |
| The General Hospital Corporation | $1,770,758 | |
| The University Of Texas Southwestern Medical Center | $340,132 | |
| University Of Notre Dame DU Lac | $160,907 | |
| The Rochester General Hospital | $455,960 | |
| The Rochester General Hospital | $33,243 | |
| The University Of Texas Southwestern Medical Center | $160,001 | |
| University Of Notre Dame DU Lac | $240,736 | |
| Vanderbilt University Medical Center | $382,202 | |
| The Rochester General Hospital | $385,761 | |
| The University Of Texas Southwestern Medical Center | $427,810 | |
| The Regents Of The University Of California. San Francisco | $388,905 | |
| Mayo Clinic Arizona | $398,316 |
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Quick answers
Who received award U01AI184071?
U01AI184071 was awarded to Mayo Clinic Jacksonville (A Nonprofit Corporation) by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on July 10, 2024.
How much is award U01AI184071 worth?
$18,388,922 has been obligated on U01AI184071.
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