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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 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 23 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05010304
The ClinicalTrials.gov registry entry for NCT05010304 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amoxicillin is the first listed.
NCT05010304 reports 0 study locations.
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.
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