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NCT03158831 · ClinicalTrials.gov registry record · Phase 1
Drug Challenges Without Prior Skin Testing
A Phase 1 study of Penicillin Allergy and Antibiotic Allergy, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 166
- Enrollment target
- 1
- Study location
NCT03158831: Completed Phase 1 study of Penicillin Allergy and Antibiotic Allergy, sponsored by Montefiore Medical Center.
NCT03158831 is a Phase 1 study of Penicillin Allergy and Antibiotic Allergy that has completed, run by Montefiore Medical Center. The registered enrollment target is 166 participants, roughly in line with the 167-participant average among 3 other Penicillin Allergy trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03158831, a Phase 1 study of Penicillin Allergy and Antibiotic Allergy, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 166 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.)
Conditions Studied
Interventions
- DRUG Placebo-Controlled Graded Drug Challenge
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2016-01-13 |
| Est. Completion | 2021-10-01 |
| Phase | Phase 1 |
What the finished NCT03158831 record still lists
NCT03158831 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 167-participant average among 3 other Penicillin Allergy trials with a reported enrollment target.
The record links to 3 conditions, with Penicillin Allergy appearing as the primary indexed condition, and to 1 intervention - of which Placebo-Controlled Graded Drug Challenge is the first listed.
NCT03158831 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03158831 about?
NCT03158831 is a clinical study titled "Drug Challenges Without Prior Skin Testing". 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...
What is the current status of trial NCT03158831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 166 participants. The study started on 2016-01-13. Estimated completion is 2021-10-01.
What conditions does trial NCT03158831 study?
This clinical trial studies the following conditions: Penicillin Allergy, Antibiotic Allergy, Drug Hypersensitivity.
What interventions are being tested in trial NCT03158831?
The interventions under investigation include: Placebo-Controlled Graded Drug Challenge (DRUG).
Who is sponsoring clinical trial NCT03158831?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03158831 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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