Trial Outcomes & Findings for Inpatient Penicillin Allergy Delabeling Study (NCT NCT05020327)
NCT ID: NCT05020327
Last Updated: 2023-07-20
Results Overview
Participants with penicillin allergy status verification based on questionnaire and challenge
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
3 hours
Results posted on
2023-07-20
Participant Flow
Participant milestones
| Measure |
Low Risk Patients
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
16
|
1
|
0
|
Reasons for withdrawal
| Measure |
Low Risk Patients
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
personal/cultural, ineligible
|
12
|
0
|
0
|
Baseline Characteristics
Inpatient Penicillin Allergy Delabeling Study
Baseline characteristics by cohort
| Measure |
Low Risk Patients
n=28 Participants
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
n=6 Participants
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
n=6 Participants
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.64 years
STANDARD_DEVIATION 4.44 • n=5 Participants
|
13 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
12.17 years
STANDARD_DEVIATION 4.383 • n=5 Participants
|
11.23 years
STANDARD_DEVIATION 4.538 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 hoursParticipants with penicillin allergy status verification based on questionnaire and challenge
Outcome measures
| Measure |
Low Risk Patients
n=28 Participants
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
n=6 Participants
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
n=6 Participants
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Number of Participants With Confirmed Allergy Status
|
28 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 hoursPopulation: Participants were not de-labeled after the questionnaire if they did not want to be de-labeled
Identification and delabeling of patients with no-risk status. These are the patients with no grounded history of reaction compatible with allergic reaction.
Outcome measures
| Measure |
Low Risk Patients
n=28 Participants
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
n=6 Participants
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
n=6 Participants
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Number of Participants With no Penicillin Allergy Confirmed and De-labelled of Penicillin Allergy Based on Results of Questionnaire.
|
11 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 hoursPopulation: Data was not collected/analyzed for the "No Risk Patients" or "High Risk".
Identification of patients who are low-risk with verified true allergy triggering referral to allergy immunology
Outcome measures
| Measure |
Low Risk Patients
n=28 Participants
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Number of Participants Categorized as Low Risk for Penicillin Allergy Reaction With Confirmed True Penicillin Allergy as Measured by Failed Oral Amoxicillin Challenge
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 hoursIdentification of patients who are high risk. These are patients identified with history of reactions compatible with true allergy. Those who are not following with allergy can be given proper referral for further evaluation and management.
Outcome measures
| Measure |
Low Risk Patients
n=28 Participants
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
n=6 Participants
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
n=6 Participants
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Number of Participants With Confirmed True Allergy Without Challenge
|
0 Participants
|
0 Participants
|
6 Participants
|
Adverse Events
Low Risk Patients
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Risk Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Risk Patients
n=28 participants at risk
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
Graded Oral Amoxicillin Challenge: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
No Risk Patients
n=6 participants at risk
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
De-labelling in electronic medical record: Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
|
High Risk
n=6 participants at risk
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
Referral to Allergy Immunology/Retention of Allergy Label: Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • 6 months
Reaction during oral challenge
|
0.00%
0/6 • 6 months
Reaction during oral challenge
|
0.00%
0/6 • 6 months
Reaction during oral challenge
|
Additional Information
Dr. Ankita Desai
University Hospitals Cleveland Medical Center
Phone: 216-844-3645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place