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NCT03158831
Drug Challenges Without Prior Skin Testing
Phase 1 trial testing Placebo-Controlled Graded Drug Challenge in Drug Hypersensitivity in 166 participants. Completed in 1 October 2021.
1 October 2021
Quick facts
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 166 |
| Start date | 13 January 2016 |
| Primary completion | 1 October 2021 |
| Estimated completion | 1 October 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placebo-Controlled Graded Drug Challenge — full drug profile →
Conditions studied
- Drug Hypersensitivity — all drugs for Drug Hypersensitivity →
- Penicillin Allergy — all drugs for Penicillin Allergy →
- Antibiotic Allergy — all drugs for Antibiotic Allergy →
Sponsor
Montefiore Medical Center
Who can join
7 and older, any sex, with Drug Hypersensitivity or Penicillin Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03158831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Drug Hypersensitivity
Currently open trials in the same condition.
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Other Montefiore Medical Center trials
Trials by the same sponsor.
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- NCT06919094 — A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults · NA · recruiting
- NCT07076069 — The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair · Phase 4 · recruiting
- NCT07037940 — Physician Response Evaluation With Contextual Insights vs. Standard Engines - Artificial Intelligence RAG vs LLM Clinica · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03158831 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
- Last refreshed: 16 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03158831.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing