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Antibiotic

Diagnostic Testing for Cephalosporin Allergy (DACAT Trial)

Phase 2

Waitlist Available

Led By Kimberly G Blumenthal, MD, MSc

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-70 years old

Be older than 18 years old

Must not have

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)

Abnormal vital signs or unstable physical exam at Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 months

Summary

"This trial aims to improve the way we diagnose and manage allergic reactions to cephalosporin antibiotics, which can be severe. The study will explore new methods to better understand and treat these allergies."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions ranging from mild skin irritation to more severe responses like anaphylaxis, which would require immediate medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I needed CPR due to a severe reaction.

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I have had a Clostridioides difficile infection before.

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I haven't taken antihistamines or steroids in the last week.

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I have not taken omalizumab or dupilumab in the last 60 days.

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I have not had an infection or taken antibiotics in the last week.

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I have taken a beta-blocker or ACE inhibitor in the last week.

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I have chronic hives or systemic mastocytosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cephalosporin skin test sensitivity and specificity

Proportion of cross-reactivity to other cephalosporins in confirmed-allergic subjects

Proportion of participants with confirmed culprit cephalosporin allergy

Secondary study objectives

Association between patient allergy history and confirmed cephalosporin allergy

Association between patient demographics and confirmed cephalosporin allergy

Cephalosporin skin test diagnostic characteristic performance differences between risk groups

+4 more

Other study objectives

Amoxicillin cross-reactivity in those with confirmed cephalosporin allergy

Amoxicillin skin test diagnostic characteristics in those with confirmed cephalosporin allergy

Cephalosporin skin test clinical statistics

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Similar cephalosporin firstExperimental Treatment5 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 firstExperimental Treatment5 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.

0 / 10Eligibility criteria met