Diagnostic Testing for Cephalosporin Allergy

(DACAT Trial)

Recruiting at 5 trial locations

Overseen By Ana D Fernandes, MA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kimberly G Blumenthal, MD, MSc

Principal Investigator

Massachusetts General Hospital

David A Khan, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

This trial is for individuals who have had allergic reactions or anaphylaxis to cephalosporin antibiotics. Participants should not currently be on beta-lactam antibiotics and must have a history of immediate reaction to at least one cephalosporin.

Inclusion Criteria

I am between 18 and 70 years old.

Reaction history consistent with a potential immediate hypersensitivity reaction to specified cephalosporin antibiotics

I speak English or have access to a translator.

Exclusion Criteria

I do not have severe heart, lung, kidney, or liver conditions.

Prison or jail inmates, pregnant women, severe cognitive impairment

My vital signs were not normal or I was physically unstable during my first visit.

Treatment Details

Interventions

• Beta-lactam antibiotic (Antibiotic)

Trial Overview The study tests the safety and effectiveness of various cephalosporins through skin testing and controlled drug challenges, aiming to improve diagnostic methods for those with suspected cephalosporin allergies.

Participant Groups

Group I: Similar cephalosporin first Experimental Treatment 5 Interventions

In visit 2, confirmed-allergic subjects will have a double-blind placebo-controlled drug challenge to a similar side chain cephalosporin, followed by a double-blind placebo-controlled challenge to a dissimilar side chain cephalosporin in visit 3. The randomization of which cephalosporin (similar or dissimilar side chain) is challenged in visits 2 and 3 differentiates the two arms.

Group II: Dissimilar cephalosporin first Experimental Treatment 5 Interventions

In visit 2, confirmed-allergic subjects will have a double-blind placebo-controlled drug challenge to a dissimilar side chain cephalosporin, followed by a double-blind placebo-controlled challenge to a similar side chain cephalosporin in visit 3. The randomization of which cephalosporin (similar or dissimilar side chain) is challenged in visits 2 and 3 differentiates the two arms.

Beta-lactam antibiotic is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Beta-lactam antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections
• Skin and soft tissue infections

Approved in Japan as Beta-lactam antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections
• Skin and soft tissue infections

Approved in China as Beta-lactam antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections
• Skin and soft tissue infections

Approved in Switzerland as Beta-lactam antibiotics for:

• Bacterial infections
• Pneumonia
• Urinary tract infections
• Skin and soft tissue infections

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+