Last reviewed · How we verify
NCT04441021
Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
trial testing Penicillin Allergy Risk Stratification and Evaluation in Penicillin Allergy in 20 participants. Completed in 29 June 2021.
1 December 2020
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 15 September 2020 |
| Primary completion | 1 December 2020 |
| Estimated completion | 29 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Penicillin Allergy Risk Stratification and Evaluation
Conditions studied
- Penicillin Allergy — all drugs for Penicillin Allergy →
Sponsor
Vanderbilt University Medical Center
Who can join
0 and older, any sex, with Penicillin Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic. Recent studies have demonstrated that a large majority of children with a penicillin allergy label do not have a true IgE-mediated allergy. Appropriately delabeling antibiotic allergies has been shown to improve patient care outcomes and lower health care costs. However, efforts to implement these assessments in practice are lacking, particularly in the hospital setting. Therefore, there is a need for hospital-based risk assessment and delabeling strategies for hospitalized children. The investigator's objective is to determine the feasibility of implementing a hospital-based approach to penicillin allergy risk stratification and evaluation of patients at low-risk for true allergy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Feasibility of a Centralized, Pharmacy-Led Penicillin Allergy Delabeling Program.
Antoon JW, Grijalva CG, Grisso AG, Stone CA, et al · · 2022 · cited 14× · PMID 35678128 · DOI 10.1542/hpeds.2021-006369 -
Breaking the Mold: Safely Delabeling Penicillin Allergies in Hospitalized Children.
Antoon JW, Grisso AG, Stone CA. · · 2021 · cited 3× · PMID 33849961 · DOI 10.1542/hpeds.2020-005280
Verify or expand the search:
- PubMed search for NCT04441021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Penicillin Allergy
Currently open trials in the same condition.
- NCT05464615 — Geisinger Antibiotic Allergy Pilot Program: Assess and Address · EARLY_PHASE1 · recruiting
- NCT07177690 — A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes · active not recruiting
Other Vanderbilt University Medical Center trials
Trials by the same sponsor.
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- NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
- NCT07224711 — The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery · Phase 4 · not yet recruiting
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 NCT04441021 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
- Last refreshed: 30 June 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/NCT04441021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing