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Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a single arm intervention pilot trial in the ICU setting, which will pave the way for a future stepped wedge randomized control trial (stepped wedge trial entered separately in clinical trials.gov as NCT03702270)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penicillin Allergic ICU Patients | Experimental | The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penicillin Allergic Risk Stratification Best Practice Alert | Other | Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Penicillin Allergy Label Removal | The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. | Hospital discharge at approximately 7 days after ICU transfer |
| Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge | The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge | Hospital discharge at approximately 7 days after ICU transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (in Particular, Reported Allergic Events) | The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events | Hospital discharge at approximately 7 days after ICU transfer |
| Communication About Penicillin Allergy in Discharge Summary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cosby A Stone, Jr., MD | Vanderbilt University Medical Center | Principal Investigator |
| Chris Lindsell, PhD | Vanderbilt University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35131513 | Derived | Koo G, Stollings JL, Lindsell C, Dear ML, Kripalani S, Nelson GE, McCoy AB, Rice TW, Phillips EJ, Stone CA Jr; Vanderbilt University Medical Center Learning Healthcare System. Low-risk penicillin allergy delabeling through a direct oral challenge in immunocompromised and/or multiple drug allergy labeled patients in a critical care setting. J Allergy Clin Immunol Pract. 2022 Jun;10(6):1660-1663.e2. doi: 10.1016/j.jaip.2022.01.041. Epub 2022 Feb 5. No abstract available. |
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Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin via informed consent, and 205/240 (85.4%) patients agreed to participate.
During the two-year period from March 2019 to March 2021, a total of 5203 patients were admitted to the MICU, and 839 (16%) patients admitted to the MICU had a PAL. Of these, 240/839 (28.6%) of MICU patients with PALs met eligibility criteria and were determined to have low-risk PALs. Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin via informed consent, and 205/240 (85.4%) patients agreed to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group- Single Arm | This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 17, 2018 |
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The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. |
| Hospital discharge at approximately 7 days after ICU transfer |
| Antibiotic Utilization by Patients | The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event | 2 years observation |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group- Single Arm | This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk. During the two-year period from March 2019 to March 2021, a total of 5203 patients were admitted to the MICU, and 839 (16%) patients admitted to the MICU had a PAL. Of these, 240/839 (28.6%) of MICU patients with PALs met eligibility criteria and were determined to have low-risk PALs. Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin, and 205/240 (85.4%) patients agreed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Penicillin Allergy Label Removal | The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. | Posted | Count of Participants | Participants | Hospital discharge at approximately 7 days after ICU transfer |
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| Primary | Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge | The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge | Baseline for this measure is those who were offered amoxicillin challenge, rather than those who agreed to it. | Posted | Count of Participants | Participants | Hospital discharge at approximately 7 days after ICU transfer |
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| Secondary | Adverse Events (in Particular, Reported Allergic Events) | The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events | Posted | Count of Participants | Participants | Hospital discharge at approximately 7 days after ICU transfer |
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| Secondary | Communication About Penicillin Allergy in Discharge Summary | The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. | Posted | Count of Participants | Participants | Hospital discharge at approximately 7 days after ICU transfer |
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| Secondary | Antibiotic Utilization by Patients | The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event | Posted | Count of Participants | Participants | 2 years observation |
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For adverse events associated with challenge, 7 days of follow up were collected. For adverse events during subsequent penicillin treatments at VUMC, 2 years of follow up data were collected.
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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 | Intervention Group- Single Arm | This study is a single arm intervention group study design in which patients with penicillin allergy labels (PALs) who were admitted to the Vanderbilt MICU were risk stratified into low-risk versus non-low risk penicillin allergies. Patients with low-risk penicillin allergies were offered the opportunity to receive a single dose 250mg amoxicillin challenge as a point of care test to remove their penicillin allergy at the point of care. Patients were potentially eligible for delabeling using amoxicillin challenge if they were hemodynamically stable, not pregnant, were cognitively capable of providing a history, (e.g. not delirious), and their PAL was low-risk. During the two-year period from March 2019 to March 2021, a total of 5203 patients were admitted to the MICU, and 839 (16%) patients admitted to the MICU had a PAL. Of these, 240/839 (28.6%) of MICU patients with PALs met eligibility criteria and were determined to have low-risk PALs. Of those who were eligible, with a low-risk PAL, all 240 patients were offered an oral challenge with amoxicillin, and 205/240 (85.4%) patients agreed. | 0 | 205 | 1 | 205 | 2 | 205 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Morbilliform Exanthem following Amoxicillin Challenge | Skin and subcutaneous tissue disorders | Systematic Assessment | Morbilliform Drug Exanthem |
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| Morbilliform Exanthem During Subsequent Penicillin Treatment at VUMC | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Intolerance During Subsequent Penicillin Treatment at VUMC | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cosby A Stone, Jr. MD, MPH | VANDERBILT UNIVERSITY MEDICAL CENTER | 6153223412 | Cosby.a.stone@vumc.org |
| Jan 10, 2022 |
| Prot_SAP_000.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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