Penicillin Allergy, Penicillin Reaction
Conditions
Keywords
penicillin, allergy
Brief 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
DRUGAmoxicillin
Two-dose amoxicillin challenge
Sponsors
American College of Allergy, Asthma and Immunology
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children from ages 2-18 years with a history of parent-reported penicillin allergy.
Exclusion criteria
* Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge | 10-14 months after amoxicillin challenge | Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Patients With a History of Penicillin Allergy Amoxicillin: Two-dose amoxicillin challenge | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Pediatric Patients With a History of Penicillin Allergy |
|---|---|
| Age, Continuous | 9.3 years STANDARD_DEVIATION 0.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Patients With a History of Penicillin Allergy | Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting | 21 Participants |
Primary
Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Patients With a History of Penicillin Allergy | Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting | 23 Participants |
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.
Time frame: 10-14 months after amoxicillin challenge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Patients With a History of Penicillin Allergy | Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge | 0 Participants |