Allergy PenicillinDOCNCT06192277
Evaluation of a Direct Oral Penicillin Challenge in a Rural Community
A study testing Screening, Low dose Penicillin and Standard dose Penicillin in people with Allergy Penicillin, run by Northern Ontario School of Medicine at 1 site in Canada.
Trial summary
This study aims to evaluate the outcomes of a rural-DOC Pilot clinic which will be established in the Huntsville site of Muskoka Algonquin Healthcare. Patients from the Muskoka region who are confirmed to have a low-risk penicillin allergy are eligible for participation in the DOC clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy Penicillin
- What is being tested?
- Screening, Low dose Penicillin and Standard dose Penicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Individuals in the Muskoka region, residing in the catchment area of Muskoka Algonquin Healthcare (Huntsville and South Muskoka site) who meet the following criteria are eligible for the study.
- Greater than 18 years of age
- In stable health
- Penicillin allergy that is either self-reported, reported by their primary care provider or previously documented in their electronic medical record
- Successfully screened to ensure they are low-risk for a penicillin allergy and have a PEN-FAST score of <3
- Screening Criteria:
Show all 16Show fewer
- Did not react to penicillin in the past 10 years
- Was never hospitalized with a penicillin reaction
- Have no evidence of a Severe Cutaneous Adverse Reaction (SCAR)
- Have no evidence of a Drug-Related Eosinophilia and Systemic Symptoms (DRESS)
- Have no history of Asthma
- Cannot recall the nature of the penicillin reaction
- Have a history of isolated non-allergic symptoms (eg. GI upset only)
- Only have a family history of penicillin reaction
- If suffer from pruritus (severe itching), with or without maculopapular rash after taking Amoxicillin
- Have no history of IgE mediated hypersensitivity reaction or angioedema
Who cannot join
- Pregnancy
- Active asthma or any other illness that will increase the participants' risk
- Do not meet the low-risk screening criteria
- Individuals who report an immune-mediated reaction to cephalosporins
- Currently taking Beta Blockers, ACE inhibitors, antihistamines or steroids at a dose greater than prednisone 10mg per day or equivalent
- If study physicians deem them not to be in stable health
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Muskoka Algonquin Healthcare
Huntsville, Ontarion, P1H1H7
Lisa Allen, 7056622901, lisa.allen@mahc.ca
About this study
Official title: Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project
This study aims to evaluate the outcomes of a rural-DOC Pilot clinic which will be established in the Huntsville site of Muskoka Algonquin Healthcare. Patients from the Muskoka region who are confirmed to have a low-risk penicillin allergy are eligible for participation in the DOC clinic. Following their experience with the DOC, participation in this study will be voluntary and feedback will be requested from each participant, and local primary care providers. The feedback will be used to assess the impact of the DOC clinic on participants and the medical community over the 2 - year study. Feedback will also be collected to investigate ongoing antimicrobial use for those participants who were successfully delabeled. This will be accomplished by surveying participants at six and twelve months after their DOC.
Read the detailed description
Penicillin has a well-established role in treating clinical infections in humans and animals. It was the first antibiotic to be mass produced and is still used worldwide. Modifications to the penicillin molecule have yielded derivatives with activity against a broader range of bacteria. However, one of the major limitations to use of penicillin is the incidence of allergic reactions to the drug. Penicillin allergies are reported in more than 10% of outpatients and 15% of inpatients. However, more than 30% of patients have no recollection of the symptoms of their adverse reaction to a medication and the inaccurate or inadequate documentation of adverse reactions can lead to misunderstood allergies. This study will challenge low risk participants to determine if they can safely take penicillin
- Conditions
- Allergy Penicillin
- Being tested
- Screening, Low dose Penicillin, Standard dose Penicillin, Remove allergy label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Also called No treatment
Patients are screened to confirm they are low risk for a penicillin allergy
Low dose PenicillinDrug
Low risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation
Standard dose PenicillinDrug
Participants who have taken the low dose of oral penicillin and have had no reaction are provided a second higher dose of penicillin (250mg) and observed for 60 minutes.
Remove allergy labelOther
Participants who have no reaction after 28 days have their penicillin allergy label removed from their electronic medical record and hospital record.
| Study group | Role | What they receive |
|---|---|---|
| Low risk | Experimental | Low risk patients will participate in the DOC challenge Receives: Other: Screening; Drug: Low dose Penicillin; Drug: Standard dose Penicillin; Other: Remove allergy label |
| High risk | No intervention | Any participant defined as more than low risk will not receive the DOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can a DOC operate in a rural community
Report on the number of staff available and who participate, and report on facility availability
Measured: 1 year
Are adequate participants available for DOC
Report on the number of participants who contact the DOC for participation
Measured: 1 year
Can participants be delableled through the DOC
Report on the number of participants who complete the DOC and are delabeled
Measured: 1 year
Number of Reactions
Report on the number and type of reaction. Report the number of participants who are not delabeled.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start6 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy PenicillinStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants are initially screened to confirm they are at a low risk of reacting to a direct oral penicillin challenge. Low-risk participants are provided oral penicillin and observed for a reaction. If no reaction occurs, (immediate or delayed up to 28 days) patients have their penicillin allergy removed from their electronic medical record with their primary care provider and the local hospital.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Ontario School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Allen, Northern Ontario School of Medicine
- Investigators
- Malcolm Wilson, MD, Study director, Muskoka Algonquin Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192277
- Sponsor's protocol ID
- DOC
- Acronym
- DOC
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentified study data as requested
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project
- ClinicalTrials.gov ID
- NCT06192277
- Acronym / sponsor ID
- DOC / DOC
- Conditions
- Allergy Penicillin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northern Ontario School of MedicineUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the outcomes of a rural-DOC Pilot clinic which will be established in the Huntsville site of Muskoka Algonquin Healthcare. Patients from the Muskoka region who are confirmed to have a low-risk penicillin allergy are eligible for participation in the DOC clinic. Following their experience with the DOC, participation in this study will be voluntary and feedback will be requested from each participant, and local primary care providers. The feedback will be used to assess the impact of the DOC clinic on participants and the medical community over the 2 - year study. Feedback will also be collected to investigate ongoing antimicrobial use for those participants who were successfully delabeled. This will be accomplished by surveying participants at six and twelve months after their DOC.
Detailed description
Penicillin has a well-established role in treating clinical infections in humans and animals. It was the first antibiotic to be mass produced and is still used worldwide. Modifications to the penicillin molecule have yielded derivatives with activity against a broader range of bacteria. However, one of the major limitations to use of penicillin is the incidence of allergic reactions to the drug. Penicillin allergies are reported in more than 10% of outpatients and 15% of inpatients. However, more than 30% of patients have no recollection of the symptoms of their adverse reaction to a medication and the inaccurate or inadequate documentation of adverse reactions can lead to misunderstood allergies. This study will challenge low risk participants to determine if they can safely take penicillin
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are initially screened to confirm they are at a low risk of reacting to a direct oral penicillin challenge. Low-risk participants are provided oral penicillin and observed for a reaction. If no reaction occurs, (immediate or delayed up to 28 days) patients have their penicillin allergy removed from their electronic medical record with their primary care provider and the local hospital.
| Arm | Type | Receives |
|---|---|---|
| Low risk | Experimental | Other: Screening, Drug: Low dose Penicillin, Drug: Standard dose Penicillin, Other: Remove allergy labelLow risk patients will participate in the DOC challenge |
| High risk | No intervention | –Any participant defined as more than low risk will not receive the DOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Individuals in the Muskoka region, residing in the catchment area of Muskoka Algonquin Healthcare (Huntsville and South Muskoka site) who meet the following criteria are eligible for the study.
- Greater than 18 years of age
- In stable health
- Penicillin allergy that is either self-reported, reported by their primary care provider or previously documented in their electronic medical record
- Successfully screened to ensure they are low-risk for a penicillin allergy and have a PEN-FAST score of <3
Key exclusion criteria (6 listed)
- Pregnancy
- Active asthma or any other illness that will increase the participants' risk
- Do not meet the low-risk screening criteria
- Individuals who report an immune-mediated reaction to cephalosporins
- Currently taking Beta Blockers, ACE inhibitors, antihistamines or steroids at a dose greater than prednisone 10mg per day or equivalent
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 |
|---|---|---|
| ScreeningAlso: No treatmentPatients are screened to confirm they are low risk for a penicillin allergy | Other | Low risk |
| Low dose PenicillinLow risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation | Drug | Low risk |
| Standard dose PenicillinParticipants who have taken the low dose of oral penicillin and have had no reaction are provided a second higher dose of penicillin (250mg) and observed for 60 minutes. | Drug | Low risk |
| Remove allergy labelParticipants who have no reaction after 28 days have their penicillin allergy label removed from their electronic medical record and hospital record. | Other | Low risk |
Primary outcome
Can a DOC operate in a rural community
Time frame: 1 year
Report on the number of staff available and who participate, and report on facility availability
Are adequate participants available for DOC
Time frame: 1 year
Report on the number of participants who contact the DOC for participation
Can participants be delableled through the DOC
Time frame: 1 year
Report on the number of participants who complete the DOC and are delabeled
Number of Reactions
Time frame: 1 year
Report on the number and type of reaction. Report the number of participants who are not delabeled.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Yes. We will share deidentified study data as requested
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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.
Malcolm Wilson, MD study director
Muskoka Algonquin Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening, Low dose Penicillin and Standard dose Penicillin in people with Allergy Penicillin, run by Northern Ontario School of Medicine at 1 site in Canada.
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 16 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Jan 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maggie Partya-Sitnik, BA (705-789-0022, magdalena.sitnik@mahc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can a DOC operate in a rural community (time frame: 1 year). The study lists 4 primary outcomes in all. 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 5 Jan 2024.