Trial Outcomes & Findings for Penicillin Allergy Testing in STD Clinics (NCT NCT04620746)
NCT ID: NCT04620746
Last Updated: 2023-09-21
Results Overview
Used yes/no questionnaire designed by study team. Any positive response on the high-risk history was grounds for exclusion from randomization to allergy testing arm
COMPLETED
PHASE4
284 participants
Baseline
2023-09-21
Participant Flow
Patients were recruited from 4 STI clinics. Enrollment criteria were whether they reported a history of having had, or been told that they have penicillin or beta-lactam allergy
All participants were administered a risk questionnaire to determine whehter they were classfied as high-risk or low risk for true penicillin allergy, based on input from allergy experts. Subjects who ahd a high risk history (eg hives within past 5 years) were referred for further allergist evaluation, as they were deemed too high risk to be evaluated further in an STI clinic
Participant milestones
| Measure |
Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
145
|
|
Overall Study
COMPLETED
|
136
|
144
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Uniterpretable skin test
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Penicillin Allergy Testing in STD Clinics
Baseline characteristics by cohort
| Measure |
Skin Testing Arm
n=139 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
Direct Oral Challenge
n=145 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
137 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
280 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
35.9 years
n=99 Participants
|
37.4 years
n=107 Participants
|
36.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
247 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
139 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineUsed yes/no questionnaire designed by study team. Any positive response on the high-risk history was grounds for exclusion from randomization to allergy testing arm
Outcome measures
| Measure |
Skin Testing Arm
n=139 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
|
Direct Oral Challenge
n=145 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
|
36 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after interventionPopulation: Number of participants analyzed is the number who completed the testing modalities
Safety was determined by the presence or absence of adverse reactions. Symptoms assessed included pruritis, flushing, shortness of breath. Physical examination included vital signs, blood pressure, pulse, respiratory rate and peak expiratory flow
Outcome measures
| Measure |
Skin Testing Arm
n=99 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
|
Direct Oral Challenge
n=103 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Safety of Direct Oral Challenge Defined by Number of Subjects Who Did Not Have Pre-defined Changes in Vital Signs or Pre-defined Emergence of New Respiratory or Skin Symptoms After Oral Challenge
|
96 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Immediately after interventionPopulation: The numbers reflected in Participants Analyzed for this outcome represent the number of participants who completed the Acceptability questionnaire.
Brief Acceptabilty Questionnaire to subjects on acceptability of PCN allergy testing in the STD clinic setting. Reported as number of participants who found testing acceptable. Questionnaire asked subjects whether they found the process helpful and whether they would return for this type of testing. Using a 1-5 scale, with 1 defined as extremely helpful and 5 defined as not helpful.
Outcome measures
| Measure |
Skin Testing Arm
n=99 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
|
Direct Oral Challenge
n=89 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire
|
99 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Response to questionnaire was optional
Provider assessment of feasibility of providing PCN testing in the STD clinic setting. This was based on a team-developed questionnaire using Likert scale questions that asked about feasibility and self-efficacy in performing the assessments. Feasibility defined by 1-5 scale, with 1= highly feasible and 5=not feasible. Reported as number of providers who found PCN testing feasible.
Outcome measures
| Measure |
Skin Testing Arm
n=11 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
|
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Provider Assessment of Feasibility of Allergy Evaluation at the End of Study
|
11 Participants
|
—
|
Adverse Events
Skin Testing Arm
Direct Oral Challenge
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Skin Testing Arm
n=139 participants at risk
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
Direct Oral Challenge
n=145 participants at risk
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
|
|---|---|---|
|
Immune system disorders
Minor adverse events
|
11.5%
16/139 • Number of events 16 • Adverse events were recorded up to 1 week post intervention
|
9.0%
13/145 • Number of events 13 • Adverse events were recorded up to 1 week post intervention
|
Additional Information
Jonathan Zenilman
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place