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
|Condition or disease||Intervention/treatment||Phase|
|Drug Hypersensitivity Penicillin Allergy Antibiotic Allergy||Drug: Placebo-Controlled Graded Drug Challenge||Phase 1|
|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)|
|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|
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.
- 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.).
- 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.
- 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
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
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Elina Jerschow, MD, MSc||Montefiore Medical Center/Albert Einstein College of Medicine|