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| Name | Class |
|---|---|
| American College of Allergy, Asthma and Immunology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Patients with a history of penicillin allergy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Two-dose amoxicillin challenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting | Day 1 | |
| Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge | Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge. | 10-14 months after amoxicillin challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36738783 | Derived | Chow TG, Patel G, Mohammed M, Johnson D, Khan DA. Delabeling penicillin allergy in a pediatric primary care clinic. Ann Allergy Asthma Immunol. 2023 May;130(5):667-669. doi: 10.1016/j.anai.2023.01.034. Epub 2023 Feb 2. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Patients With a History of Penicillin Allergy | Amoxicillin: Two-dose amoxicillin challenge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Patients With a History of Penicillin Allergy | Amoxicillin: Two-dose amoxicillin challenge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting | Posted | Count of Participants | Participants | Day 1 |
|
|
7 days after amoxicillin challenge completion
Adverse events were captured by study staff during the 60 minute observation period with amoxicillin challenge, and again assessed at 7 days after challenge completion by study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Patients With a History of Penicillin Allergy | Amoxicillin: Two-dose amoxicillin challenge |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Cutaneous-only reaction, resolving with oral antihistamines |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Timothy Chow | University of Texas Southwestern | 2144569093 | timothy.chow@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2021 | Jul 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2021 | Jul 23, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge | Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge. | Posted | Count of Participants | Participants | 10-14 months after amoxicillin challenge |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |