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NCT05010304 · ClinicalTrials.gov registry record · Phase 4
Penicillin De-labeling in the Pediatric Primary Care Setting
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT05010304: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT05010304 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05010304, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.
Interventions
- DRUG Amoxicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 4 |
What the finished NCT05010304 record still lists
NCT05010304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Amoxicillin is the first listed.
NCT05010304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05010304 about?
NCT05010304 is a clinical study titled "Penicillin De-labeling in the Pediatric Primary Care Setting". While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling stra...
What is the current status of trial NCT05010304?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2021-12-09. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT05010304?
The interventions under investigation include: Amoxicillin (DRUG).
Who is sponsoring clinical trial NCT05010304?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05010304's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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