Penicillin AllergyPhase 4NCT04620746
Penicillin Allergy Testing in STD Clinics
A Phase 4 study testing Penicillin Major Determinant (PrePen) Skin Testing and Direct Oral challenge in people with Penicillin Allergy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Penicillin Major Determinant (PrePen) Skin Testing and Direct Oral challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prior history of PCN allergy
Who cannot join
- No immunodeficiency or contraindication to skin testing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louisiana State University
New Orleans, Louisiana, 70112
University of Washington-Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
Read the 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
- Conditions
- Penicillin Allergy
- Being tested
- Penicillin Major Determinant (PrePen) Skin Testing, Direct Oral challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin Major Determinant (PrePen) Skin TestingDrug
Also called Penicillin G Minor Determinant Skin Testing
Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challengeDrug
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Skin Testing Arm | Active comparator | These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Receives: Drug: Penicillin Major Determinant (PrePen) Skin Testing; Drug: Direct 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 Receives: Drug: Direct Oral challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 minutes after intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penicillin AllergyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Wake Forest University Health Sciences, Louisiana State University Health Sciences Center in New Orleans, University of Washington
- Responsible party
- Sponsor
- Investigators
- Jonathan M Zenilman, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620746
- Sponsor's protocol ID
- IRB00220384
- Other IDs
- HHSN272201300012I/HHSN27200015
- Status last verified
- Sep 2023
- First submitted
- 3 Nov 2020
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Blinded data set is available
Publications
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.
PubMed 38325290
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients
- ClinicalTrials.gov ID
- NCT04620746
- Acronym / sponsor ID
- IRB00220384
- Conditions
- Penicillin Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Indiana University, Wake Forest University Health Sciences, Louisiana State University Health Sciences Center in New Orleans, University of Washington
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Testing Arm | Active comparator | Drug: Penicillin Major Determinant (PrePen) Skin Testing, Drug: Direct Oral challengeThese subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge |
| Direct Oral Challenge | Active comparator | Drug: Direct Oral challengeThese subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prior history of PCN allergy
Key exclusion criteria (1 listed)
- No immunodeficiency or contraindication to skin testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penicillin Major Determinant (PrePen) Skin TestingAlso: Penicillin G Minor Determinant Skin TestingSkin testing followed by oral challenge with amoxicillin 250 mg single dose | Drug | Skin Testing Arm |
| Direct Oral challengeDirect oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose | Drug | Direct Oral Challenge, Skin Testing Arm |
Primary outcome
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
Time frame: 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
Time frame: 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
2 secondary outcomes
Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire
Time frame: Immediately after intervention
Provider Assessment of Feasibility of Allergy Evaluation at the End of Study
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38325290Lillis 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.
- Individual participant dataSharing planned: Yes. Blinded data set is available
Related trials for Penicillin Allergy
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Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
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Allergy Delabeling in Antibiotic Stewardship - Intervention
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Allergy Delabeling in Antibiotic Stewardship - Evaluations
Beta Lactam Allergy in Patients With a Hematologic Malignancy
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Provocation After Nurse-Directed Assessment (PANDA) Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M Zenilman principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Penicillin Major Determinant (PrePen) Skin Testing and Direct Oral challenge in people with Penicillin Allergy, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.