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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201300012I/HHSN27200015 | Other Grant/Funding Number | National Institute Of Allergy & Infectious Disease |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| Wake Forest University Health Sciences | OTHER |
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
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Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Testing Arm | Active Comparator | These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge |
|
| Direct Oral Challenge | Active Comparator | These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penicillin Major Determinant (PrePen) Skin Testing | Drug | Skin testing followed by oral challenge with amoxicillin 250 mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| 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 | 30 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan M Zenilman | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University | New Orleans | Louisiana | 70112 | United States | ||
| University of Washington-Harborview Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38325290 | Derived | Lillis RA, Barbee LA, McNeil CJ, Newman L, Fortenberry JD, Alvarez-Arango S, Zenilman JM. Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients. Clin Infect Dis. 2024 May 15;78(5):1131-1139. doi: 10.1093/cid/ciae064. |
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Blinded data set is available
Data will be uploaded and provided when study is completed and analyzed. Completed May 2023
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline |
|
Adverse events were recorded up to 1 week post intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor adverse events | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Zenilman | Johns Hopkins University School of Medicine | 410-550-9080 | jzenilm1@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2022 | Jun 1, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2022 | Jun 1, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2020 | Jun 2, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012882 | Skin Tests |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| University of Washington |
| OTHER |
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| Direct Oral challenge | Drug | Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose |
|
| Immediately after intervention |
| 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. | 18 months |
| Seattle |
| Washington |
| 98104 |
| United States |
| Withdrawal by Subject |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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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 |
|
|
| 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 | Number of participants analyzed is the number who completed the testing modalities | Posted | Count of Participants | Participants | 30 minutes after intervention |
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|
|
|
| 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. | The numbers reflected in Participants Analyzed for this outcome represent the number of participants who completed the Acceptability questionnaire. | Posted | Count of Participants | Participants | Immediately after intervention |
|
|
|
|
| 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. | Response to questionnaire was optional | Posted | Count of Participants | Participants | 18 months |
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| 0 |
| 139 |
| 0 |
| 139 |
| 16 |
| 139 |
| EG001 | 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 | 0 | 145 | 0 | 145 | 13 | 145 |
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| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |