Penicillin Allergy
Conditions
Brief summary
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
Detailed description
all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge
Interventions
DRUGPenicillin Major Determinant (PrePen) Skin Testing
Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Sponsors
Indiana University School of Medicine
Wake Forest University Health Sciences
Louisiana State University Health Sciences Center in New Orleans
University of Washington
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Prior history of PCN allergy
Exclusion criteria
* No immunodeficiency or contraindication to skin testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study | Baseline | 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 |
| 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 | 30 minutes after intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire | Immediately after intervention | 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. |
| Provider Assessment of Feasibility of Allergy Evaluation at the End of Study | 18 months | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 139 |
| 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 | 145 |
| Total | 284 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Uniterpretable skin test | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Skin Testing Arm | Direct Oral Challenge | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants | 143 Participants | 280 Participants |
| Age, Continuous | 35.9 years | 37.4 years | 36.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 15 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 130 Participants | 247 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 42 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 104 Participants | 90 Participants | 194 Participants |
| Region of Enrollment United States | 139 Participants | 145 Participants | 284 Participants |
| Sex: Female, Male Female | 45 Participants | 41 Participants | 86 Participants |
| Sex: Female, Male Male | 94 Participants | 104 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 145 |
| other Total, other adverse events | 16 / 139 | 13 / 145 |
| serious Total, serious adverse events | 0 / 139 | 0 / 145 |
Outcome results
Primary
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
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
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Testing Arm | Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study | 36 Participants |
| Direct Oral Challenge | Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study | 36 Participants |
Primary
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
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
Time frame: 30 minutes after intervention
Population: Number of participants analyzed is the number who completed the testing modalities
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Testing Arm | 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 |
| Direct Oral Challenge | 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 | 95 Participants |
p-value: 0.98Chi-squared, Corrected
Secondary
Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed 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.
Time frame: Immediately after intervention
Population: The numbers reflected in Participants Analyzed for this outcome represent the number of participants who completed the Acceptability questionnaire.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Testing Arm | Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire | 99 Participants |
| Direct Oral Challenge | Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire | 89 Participants |
p-value: 0.95Chi-squared
Secondary
Provider Assessment of Feasibility of Allergy Evaluation at the End of Study
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.
Time frame: 18 months
Population: Response to questionnaire was optional
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Testing Arm | Provider Assessment of Feasibility of Allergy Evaluation at the End of Study | 11 Participants |