Penicillin AllergyNCT03702270
The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
A study testing Penicillin Allergic Risk Stratification Best Practice Alert in people with Penicillin Allergy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means… 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 Allergic Risk Stratification Best Practice Alert
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,052 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 11 May 2023
- Phase
- Interventional
- 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
- VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.
Who cannot join
- Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.
- Conditions
- Penicillin Allergy
- Being tested
- Penicillin Allergic Risk Stratification Best Practice Alert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin Allergic Risk Stratification Best Practice AlertOther
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
| Study group | Role | What they receive |
|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Experimental | The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk. Receives: Other: Penicillin Allergic Risk Stratification Best Practice Alert |
| Penicillin Allergic Floor Patients- Control | No intervention | Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penicillin Allergy Label Removal
The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Measured: Hospital discharge at approximately 4 days after admission
Secondary outcomes (8)
Adverse Events (in Particular, Reported Allergic Events)
The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events
Measured: Hospital discharge at approximately 4 days after admission
Communication About Penicillin Allergy in Discharge Summary
The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Measured: Hospital discharge at approximately 4 days after admission
Antibiotic Utilization by Patients
The number of changes or new starts of penicillin or cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Measured: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Durability of Penicillin Allergy Label Removal
The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.
Measured: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Receipt of Risk Stratification Tool Assessment
Number of patients with a penicillin allergy label who received a risk assessment.
Measured: Hospital discharge at approximately 4 days after admission
Time to Penicillin Allergy Label Return
For those patients who underwent a penicillin allergy label removal and it returns, we will compare the date the allergy label returned with the date it was removed
Measured: From 3-18 months of follow up
Penicillin Utilization by Patients
The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Measured: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Cephalosporin Utilization by Patients
The number of changes or new starts of cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Measured: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start11 Nov 2020
- Primary completion11 Dec 2021
- Study completion11 May 2023
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.
- Other trials for Penicillin AllergyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will be assigned to clusters. A single cluster will be selected for intervention at the outset of the trial. Subsequent additional clusters will first contribute to the control group, and be selected to randomly cross over to the intervention group at regular intervals of 1 months.
- Masking
- None (open label)
- Enrolment
- 2,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cosby Stone, Vanderbilt University Medical Center
- Investigators
- Cosby Stone, MD, MPH, Principal investigator, Vanderbilt University Medical CenterChris Lindsell, PhD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702270
- Sponsor's protocol ID
- 181734
- Status last verified
- Dec 2024
- First submitted
- 8 Oct 2018
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
- ClinicalTrials.gov ID
- NCT03702270
- Acronym / sponsor ID
- 181734
- Conditions
- Penicillin Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,052 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will be assigned to clusters. A single cluster will be selected for intervention at the outset of the trial. Subsequent additional clusters will first contribute to the control group, and be selected to randomly cross over to the intervention group at regular intervals of 1 months.
| Arm | Type | Receives |
|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Experimental | Other: Penicillin Allergic Risk Stratification Best Practice AlertThe intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk. |
| Penicillin Allergic Floor Patients- Control | No intervention | –Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.
Key exclusion criteria (2 listed)
- Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.
- Pregnant patients
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 Allergic Risk Stratification Best Practice AlertProviding best practice information on a patient's penicillin allergy risk and how to manage different levels of risk. | Other | Penicillin Allergic Floor Patients- Experimental |
Primary outcome
Penicillin Allergy Label Removal
Time frame: Hospital discharge at approximately 4 days after admission
The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
8 secondary outcomes
Adverse Events (in Particular, Reported Allergic Events)
Time frame: Hospital discharge at approximately 4 days after admission
Communication About Penicillin Allergy in Discharge Summary
Time frame: Hospital discharge at approximately 4 days after admission
Antibiotic Utilization by Patients
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Durability of Penicillin Allergy Label Removal
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Receipt of Risk Stratification Tool Assessment
Time frame: Hospital discharge at approximately 4 days after admission
Time to Penicillin Allergy Label Return
Time frame: From 3-18 months of follow up
Penicillin Utilization by Patients
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Cephalosporin Utilization by Patients
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
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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.
Cosby Stone, MD, MPH principal investigator
Vanderbilt University Medical Center
Chris Lindsell, PhD study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penicillin Allergic Risk Stratification Best Practice Alert in people with Penicillin Allergy, run by Vanderbilt University Medical Center at 1 site 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 2 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). 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?
Penicillin Allergy Label Removal (time frame: Hospital discharge at approximately 4 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.