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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 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 40 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05020327
The ClinicalTrials.gov registry entry for NCT05020327 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Graded Oral Amoxicillin Challenge is the first listed.
NCT05020327 reports 0 study locations.
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.
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