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NCT05020327 · ClinicalTrials.gov registry record · Phase 4
Inpatient Penicillin Allergy Delabeling Study
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT05020327: Completed Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
NCT05020327 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05020327, a Phase 4 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The study will identify pediatric patients 3-18 years old who have penicillin allergy label in the electronic medical record. Those who are identified will be stratified into no-risk, low-risk and high-risk category using a screening questionnaire. The following definitions will be followed: No-risk: Patients who are historically labeled with penicillin allergy in the EMR based on family history alone OR those who have tolerated penicillin after a concerning incident without any reaction OR with penicillin allergy label but deny any history of reaction to any form of penicillin on screening questionnaire Low-risk: Patients with previous reaction not suggestive of anaphylaxis (defined below) AND not requiring hospitalization for the reaction OR reaction considered non- immunologic (e.g. diarrhea, nausea, yeast vaginitis) OR exposure to penicillin- containing antibiotic after the date of reported reaction with no anaphylaxis and hospitalization AND no serious types of delayed reactions such as Steven- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum sickness. Patients who had delayed reaction (onset more than 24 hours) of isolated, non-progressive symptoms (such as rash/hives alone) also belong to this group. High-risk: Patients with penicillin allergy label on EMR with previous reaction suggestive of anaphylaxis (defined below) OR requiring hospitalization/epinephrine administration for the reaction OR reactions considered immunologic (angioedema, joint pains) OR involving serious types of reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum s
Primary Outcome
Participants with penicillin allergy status verification based on questionnaire and challenge
Interventions
- DRUG Graded Oral Amoxicillin Challenge
- OTHER De-labelling in electronic medical record
- OTHER Referral to Allergy Immunology/Retention of Allergy Label
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 4 |
What the finished NCT05020327 record still lists
NCT05020327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Graded Oral Amoxicillin Challenge is the first listed.
NCT05020327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05020327 about?
NCT05020327 is a clinical study titled "Inpatient Penicillin Allergy Delabeling Study". The study will identify pediatric patients 3-18 years old who have penicillin allergy label in the electronic medical record. Those who are identified will be stratified into no-risk, low-risk and high-risk category using a screening questionnaire. The following definitions will be followed: No-ris...
What is the current status of trial NCT05020327?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2021-09-22. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT05020327?
The interventions under investigation include: Graded Oral Amoxicillin Challenge (DRUG), De-labelling in electronic medical record (OTHER), Referral to Allergy Immunology/Retention of Allergy Label (OTHER).
Who is sponsoring clinical trial NCT05020327?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05020327's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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