Drug Challenges Without Prior Skin Testing

PHASE1CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

January 13, 2016

Primary Completion Date

October 1, 2021

Study Completion Date

October 1, 2021

Conditions
Drug HypersensitivityPenicillin AllergyAntibiotic Allergy
Interventions
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.

Trial Locations (1)

10461

Montefiore Medical Center, The Bronx

All Listed Sponsors
lead

Montefiore Medical Center

OTHER

NCT03158831 - Drug Challenges Without Prior Skin Testing | Biotech Hunter | Biotech Hunter