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Drug Challenges Without Prior Skin Testing

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ClinicalTrials.gov Identifier: NCT03158831
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Elina Jerschow, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Drug Hypersensitivity Penicillin Allergy Antibiotic Allergy Drug: Placebo-Controlled Graded Drug Challenge Phase 1

Detailed Description:
Graded drug challenges are the gold standard to exclude an immediate hypersensitivity reaction in patients with a low likelihood of drug allergy and are considered standard of care. Patients who tolerate a graded challenge are deemed to not be allergic to the drug and are not at increased risk for future reactions compared with the general population. Prior studies of graded challenges in appropriately selected patients have demonstrated low reaction rates with symptoms that were mainly mild and subjective in nature. 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. Skin testing requires a separate visit and is, therefore, more time-consuming and costly than performing a graded challenge without skin testing. The investigators believe that they can determine if patients are at low-risk to react to an antibiotic based on a detailed history and, therefore, do not require skin testing prior to a challenge. Given the majority of symptoms to graded drug challenges reported in prior studies were mild and subjective, 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 be not meaningfully more than the rate of adverse reactions with prior skin testing as was observed in the investigators' historical clinic cohort. All patients age 7 years or older with a history of a non-life-threatening reaction to an antibiotic are eligible to participate in a placebo-controlled graded drug challenge. The challenge is comprised of placebo followed by 30 minutes of observation, 1/10th of the treatment dose of the antibiotic the patient reported a reaction followed by 30 minutes of observation, and the full dose of the antibiotic followed by 1 hour of observation. All patients will be contacted via telephone within one month of a negative challenge to determine whether they experienced a delayed reaction. All patients will also be contacted via telephone within one year of a negative challenge to determine if they have safely taken the challenge drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Drug Challenges Without Prior Skin Testing
Actual Study Start Date : January 13, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo-Controlled Graded Drug Challenge
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
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.




Primary Outcome Measures :
  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. [ Time Frame: It is anticipated the study will take 2 years to enroll 200 patients with subsequent data comparison. ]
    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.).


Secondary Outcome Measures :
  1. Rate of unexpected reaction to graded drug challenges versus placebos [ Time Frame: Patients are monitored for 1 hour after completion of their drug challenge. ]
    Determine the rate of unexpected reaction to graded drug challenges without prior skin tests versus the rate of unexpected reaction to placebos in patients with a low-risk history of drug hypersensitivity reaction based on history alone.

  2. Rate of unexpected delayed reaction to graded drug challenges [ Time Frame: Patients are called within 1 month of their challenge to determine if they had any delayed reactions. ]
    Determine the rate of unexpected delayed reaction to graded challenges



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158831


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Elina Jerschow, MD, MSc Montefiore Medical Center/Albert Einstein College of Medicine

Publications:
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Responsible Party: Elina Jerschow, Associate Professor of Clinical Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03158831     History of Changes
Other Study ID Numbers: 2015-5610
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Elina Jerschow, Montefiore Medical Center:
Drug Allergy
Penicillin Allergy
Antibiotic Allergy
Graded Drug Challenge
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders