Drug Challenges Without Prior Skin Testing

NCT03158831 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2015-5610
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are conducting a prospective study to determine the safety and outcomes of placebo-controlled graded drug challenges without prior skin testing in patients with a low-risk history of antibiotic hypersensitivity reaction based on history alone. The investigators hypothesize that the rate of reaction to graded drug challenges without prior skin testing in patients with a low-risk history of drug hypersensitivity reaction based on history alone will not be meaningfully more than the rate of reaction to placebo. The investigators hypothesize that the rate of adverse reactions to drug challenges without prior skin testing will not be meaningfully more than the rate of adverse reactions with prior skin testing as was observed in the investigators' historical clinic cohort.

Conditions

Drug Hypersensitivity; Penicillin Allergy; Antibiotic Allergy

Keywords

Drug Allergy; Penicillin Allergy; Antibiotic Allergy; Graded Drug Challenge

Outcome Measures

Primary Outcomes (1)

• Rate of unexpected reaction to graded drug challenges without prior skin testing compared to rate of unexpected reaction to graded drug challenges with prior skin testing.

  Determine the rate of unexpected reaction to a graded drug challenge without prior skin testing versus the rate of reaction to a graded drug challenge with prior skin testing in the investigators' historical cohort (data on this cohort has already been published: Iammatteo M, Ferastraoaru D, Koransky R, Alvarez-Arango S, Thota N, Akenroye A, Jerschow E. Identifying Allergic Drug Reactions Through Placebo-Controlled Graded Challenges. J Allergy Clin Immunol Pract. 2017 May - Jun;5(3):711-717.e2.).

  It is anticipated the study will take 2 years to enroll 200 patients with subsequent data comparison.

Secondary Outcomes (2)

• Rate of unexpected reaction to graded drug challenges versus placebos

  Patients are monitored for 1 hour after completion of their drug challenge.

• Rate of unexpected delayed reaction to graded drug challenges

  Patients are called within 1 month of their challenge to determine if they had any delayed reactions.

Study Arms (1)

Placebo-Controlled Graded Drug Challenge

OTHER

This is a single arm study. All patients will receive a placebo prior to a graded drug challenge. Each patient serves as his/her own control.

Drug: Placebo-Controlled Graded Drug Challenge

Interventions

Placebo-Controlled Graded Drug Challenge DRUG

All patients receive a placebo followed by 30 minutes of observation. Patients then receive 1/10 of the treatment dose of the challenge drug followed by 30 minutes of observation. If no reaction, they will then receive a full dose of their challenge drug followed by 1 hour of observation. If they do not experience any reactions, they are deemed not to be allergic. All patients are asked to monitor for delayed reactions after the challenge. Patients are also called within 1 month of the challenge to determine if any delayed reactions occurred. Patients are called again within 1 year of the challenge to determine if they have subsequently taken the challenge drug and experienced any reactions.

Placebo-Controlled Graded Drug Challenge

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients seven years of age or older who have a low-risk, non-life-threatening history of adverse reaction to an antibiotic.

You may not qualify if:

• Patients under the age of seven.
• Pregnant patients.
• Patients with a history of a drug reaction that is high-risk and life-threatening including life-threatening angioedema, bronchospasm, or anaphylactic shock or a history of severe non-IgE-mediated reactions including serum sickness, Stevens-Johnson syndrome, toxic epidermal necrolysis, interstitial nephritis, hepatitis, hemolytic anemia, DRESS, skin and/or oral blisters, hypersensitivity vasculitis, pneumonitis, or pulmonary fibrosis.
• Patients who have taken antihistamines within 3 days of the drug challenge.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (4)

• Iammatteo M, Ferastraoaru D, Koransky R, Alvarez-Arango S, Thota N, Akenroye A, Jerschow E. Identifying Allergic Drug Reactions Through Placebo-Controlled Graded Challenges. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):711-717.e2. doi: 10.1016/j.jaip.2016.09.041. Epub 2016 Nov 23.

  PMID: 27888028 BACKGROUND

• Iammatteo M, Blumenthal KG, Saff R, Long AA, Banerji A. Safety and outcomes of test doses for the evaluation of adverse drug reactions: a 5-year retrospective review. J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):768-74. doi: 10.1016/j.jaip.2014.08.001. Epub 2014 Sep 10.

  PMID: 25439369 BACKGROUND

• Macy E, Romano A, Khan D. Practical Management of Antibiotic Hypersensitivity in 2017. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):577-586. doi: 10.1016/j.jaip.2017.02.014. Epub 2017 Mar 29.

  PMID: 28365277 BACKGROUND

• Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.

  PMID: 20934625 BACKGROUND

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Elina Jerschow, MD, MSc

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Model Details: Prospective interventional study whereby each eligible patient undergoes a placebo-controlled graded challenge. Each patient receives a placebo prior to undergoing a graded challenge to 1/10 the treatment dose of the challenge drug followed by a full treatment dose of the challenge drug.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 18, 2017
• Study Start: January 13, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)