Trial Outcomes & Findings for Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting (NCT NCT03702283)

Last Updated: 2022-05-13

Results Overview

The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.

Recruitment status

COMPLETED

Study phase

Target enrollment

240 participants

Primary outcome timeframe

Hospital discharge at approximately 7 days after ICU transfer

Results posted on

2022-05-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	205
Overall Study COMPLETED	205
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group- Single Arm n=205 Participants 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.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	202 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	179 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	205 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group- Single Arm n=205 Participants 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.
Penicillin Allergy Label Removal	201 Participants

PRIMARY outcome

Timeframe: 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.

The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge

Outcome measures

Outcome measures
Measure	Intervention Group- Single Arm n=240 Participants 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.
Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge	205 Participants

SECONDARY outcome

Timeframe: Hospital discharge at approximately 7 days after ICU transfer

The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events

Outcome measures

Outcome measures
Measure	Intervention Group- Single Arm n=205 Participants 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.
Adverse Events (in Particular, Reported Allergic Events)	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group- Single Arm n=205 Participants 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.
Communication About Penicillin Allergy in Discharge Summary	202 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention Group- Single Arm n=205 Participants 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.
Antibiotic Utilization by Patients	59 Participants

Adverse Events

Intervention Group- Single Arm

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Group- Single Arm n=205 participants at risk 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.
Skin and subcutaneous tissue disorders Morbilliform Exanthem following Amoxicillin Challenge	0.49% 1/205 • Number of events 1 • 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.
Gastrointestinal disorders Morbilliform Exanthem During Subsequent Penicillin Treatment at VUMC	0.49% 1/205 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Intervention Group- Single Arm n=205 participants at risk 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.
Gastrointestinal disorders Gastrointestinal Intolerance During Subsequent Penicillin Treatment at VUMC	0.98% 2/205 • Number of events 2 • 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.

Additional Information

Cosby A Stone, Jr. MD, MPH

VANDERBILT UNIVERSITY MEDICAL CENTER

Phone: 6153223412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place