Penicillin Allergy
Conditions
Brief summary
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)
Interventions
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* VUMC patients age 18 or older with a penicillin allergy reported in their chart and are medically stable, currently admitted to ICU.
Exclusion criteria
* Patients with a penicillin allergy reported in their chart under ICU care, but who are currently medically unstable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penicillin Allergy Label Removal | Hospital discharge at approximately 7 days after ICU transfer | The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. |
| Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge | Hospital discharge at approximately 7 days after ICU transfer | The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (in Particular, Reported Allergic Events) | Hospital discharge at approximately 7 days after ICU transfer | The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events |
| Communication About Penicillin Allergy in Discharge Summary | Hospital discharge at approximately 7 days after ICU transfer | The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. |
| Antibiotic Utilization by Patients | 2 years observation | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 205 |
| Total | 205 |
Baseline characteristics
| Characteristic | Intervention Group- Single Arm |
|---|---|
| Age, Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 202 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 21 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 | 3 Participants |
| Race (NIH/OMB) White | 179 Participants |
| Region of Enrollment United States | 205 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 205 |
| other Total, other adverse events | 2 / 205 |
| serious Total, serious adverse events | 1 / 205 |
Outcome results
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
Time frame: Hospital discharge at approximately 7 days after ICU transfer
Population: Baseline for this measure is those who were offered amoxicillin challenge, rather than those who agreed to it.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group- Single Arm | Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge | 205 Participants |
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.
Time frame: Hospital discharge at approximately 7 days after ICU transfer
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group- Single Arm | Penicillin Allergy Label Removal | 201 Participants |
Secondary
Adverse Events (in Particular, Reported Allergic Events)
The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events
Time frame: Hospital discharge at approximately 7 days after ICU transfer
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group- Single Arm | Adverse Events (in Particular, Reported Allergic Events) | 1 Participants |
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
Time frame: 2 years observation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group- Single Arm | Antibiotic Utilization by Patients | 59 Participants |
Secondary
Communication About Penicillin Allergy in Discharge Summary
The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Time frame: Hospital discharge at approximately 7 days after ICU transfer
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group- Single Arm | Communication About Penicillin Allergy in Discharge Summary | 202 Participants |