Penicillin AllergyNCT04408508
Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients
A study testing Amoxicillin 250 MG in people with Penicillin Allergy, run by Saskatchewan Health Authority - Regina Area.
Trial summary
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, less than 5%-10% of them have a confirmed allergy following comprehensive investigations. 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?
- Amoxicillin 250 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jun 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
- Assessed to be low risk of having a penicillin allergy as per the risk stratification questionnaire
- One of the following: i) An unknown reaction >10 years before, ii) A type A adverse drug reaction (pharmacologically predictable drug side effect or intolerance), or iii) A history of a benign childhood rash, nonurticarial rash, or maculopapular exanthem more than 10 years ago
- Age 18 years or older
- Hemodynamically stable and suitable for discharge home
Who cannot join
- Declines participation in the study
- Cognitive impairment and where a collateral history could not be obtained
- History of anaphylaxis or angioedema attributed to a penicillin-based antibiotic
- History of severe cutaneous adverse reactions attributed to a penicillin-based antibiotic
- History of acute kidney injury or severe liver impairment attributed to a penicillin-based antibiotic
- Currently taking an angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker or a beta blocker
Show all 9Show fewer
- Hemodynamically unstable
- History of idiopathic urticaria or idiopathic anaphylaxis
- Currently taking an antibiotic(s) for treatment of an active infection
Trial locations and contacts
No sites are listed yet.
About this study
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, less than 5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship.
There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Direct oral amoxicillin challenges are safe and effective in delabeling low risk patients who report penicillin allergy in large paediatric and adult studies and does not necessitate specialist referral.
The study team seeks to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). The study investigators will determine the number of patients successfully delabelled of their "penicillin allergy" prior to discharge from hospital over a 12 month period. The study doctors will also assess the economic impact of the investigator's model and ease of implementation in the busy inpatient setting. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabelled.
Read the detailed description
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, only <5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship. There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Consequently, patients with a penicillin allergy label receive alternative antibiotics such as carbapenems, fluoroquinolones, and vancomycin for the treatment of common and serious infections and for pre-surgical prophylaxis. Patients with penicillin allergy label have longer hospital stays and higher rates of infections with Clostridioides (Clostridium) difficile, VRE and MRSA in comparison with patients without a documented allergy.
Direct oral amoxicillin challenges are safe and effective in delabeling patients stratified as low risk for penicillin allergy in large pediatric and adult studies. Low-risk penicillin allergy histories include patients who have had isolated nonallergic symptoms (eg, gastrointestinal symptoms) or patients solely with a family history of a penicillin allergy, pruritus without rash, or remote (>10 years) unknown reactions without features suggestive of an IgE-mediated reaction.
The study investigators seek to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). Identified patients that fulfill the exclusion and inclusion criteria will be reviewed at the time of discharge for suitability, as per the algorithm, modelled after a previous study of similar design. Based on patient's reported allergy, and upon obtaining informed consent, participants will receive a supervised challenge of amoxicillin 250 mg once orally and subsequently observed for 1 hour before discharge home. After antibiotic challenge, patient outcome will be defined as (1) tolerated oral challenge with no adverse drug reaction or (2) adverse drug reaction.
By challenging carefully selected low risk patient that are unlikely to be truly allergic while in hospital, the study doctors can delabel patients of their "penicillin allergy" and as a result cut health care expenditures and promote good antimicrobial stewardship. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabeled.
- Conditions
- Penicillin Allergy
- Being tested
- Amoxicillin 250 MG
- Keywords
- beta-lactam, penicillin, hypersensitivity, drug allergy
- Medical subject headings
- Hypersensitivity, Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 250 MGDrug
Also called Amoxicillin 250 mg Capsule
Low dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin administration | Other | Oral amoxicillin administered to study patients Receives: Drug: Amoxicillin 250 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients tolerating oral amoxicillin challenge
The number of patients tolerating a single dose oral amoxicillin (250 mg) challenge without adverse reaction(s) up to one hour of administration
Measured: 12 months
Secondary outcomes (4)
Number of patients reporting a delayed reaction to amoxicillin
Number of patients reporting a delayed reaction to amoxicillin (between 1 hour - 12 weeks) following observation and discharge from hospital
Measured: 12 months
Average delay in discharge attributable to amoxicillin challenge
Average delay in discharge (minutes) attributable to penicillin challenge, recorded by the resident or staff physician performing the questionnaire
Measured: 12 months
The number of patients excluded from the study due to staff time constraints
Number of patients excluded from the study due to resident/staff time constraints
Measured: 12 months
Type of immediate reaction attributed to the oral amoxicillin: maculopapular rash, urticaria, angioedema, airway compromise, diarrhea, vomiting or other (including subjective symptoms)
Nature of immediate adverse reaction if challenge unsuccessful
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Penicillin AllergyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients reporting penicillin allergy will be enrolled based on eligibility criteria for direct oral amoxicillin challenge. There will be one treatment group of patients assigned low risk for penicillin allergy.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Fong, MD, FRCPC, Principal investigator, Saskatchewan Health Authority - Regina Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408508
- Sponsor's protocol ID
- REB-19-97
- Status last verified
- Apr 2023
- First submitted
- 3 Feb 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No only agregate data will be shared
Publications
Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.
PubMed 20934625Macy E. Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs. Curr Opin Allergy Clin Immunol. 2015 Aug;15(4):308-13. doi: 10.1097/ACI.0000000000000173.
PubMed 26110680Macy E, Ngor EW. Safely diagnosing clinically significant penicillin allergy using only penicilloyl-poly-lysine, penicillin, and oral amoxicillin. J Allergy Clin Immunol Pract. 2013 May-Jun;1(3):258-63. doi: 10.1016/j.jaip.2013.02.002. Epub 2013 Apr 6.
PubMed 24565482Mohamed OE, Beck S, Huissoon A, Melchior C, Heslegrave J, Baretto R, Ekbote A, Krishna MT. A Retrospective Critical Analysis and Risk Stratification of Penicillin Allergy Delabeling in a UK Specialist Regional Allergy Service. J Allergy Clin Immunol Pract. 2019 Jan;7(1):251-258. doi: 10.1016/j.jaip.2018.05.025. Epub 2018 Jun 5.
PubMed 29883754Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.
PubMed 24188976Mill C, Primeau MN, Medoff E, Lejtenyi C, O'Keefe A, Netchiporouk E, Dery A, Ben-Shoshan M. Assessing the Diagnostic Properties of a Graded Oral Provocation Challenge for the Diagnosis of Immediate and Nonimmediate Reactions to Amoxicillin in Children. JAMA Pediatr. 2016 Jun 6;170(6):e160033. doi: 10.1001/jamapediatrics.2016.0033. Epub 2016 Jun 6.
PubMed 27043788Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):813-815. doi: 10.1016/j.jaip.2017.01.023. Epub 2017 Mar 21. No abstract available.
PubMed 28341170Labrosse R, Paradis L, Lacombe-Barrios J, Samaan K, Graham F, Paradis J, Begin P, Des Roches A. Efficacy and Safety of 5-Day Challenge for the Evaluation of Nonsevere Amoxicillin Allergy in Children. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1673-1680. doi: 10.1016/j.jaip.2018.01.030. Epub 2018 Feb 7.
PubMed 29425903Iammatteo M, Alvarez Arango S, Ferastraoaru D, Akbar N, Lee AY, Cohen HW, Jerschow E. Safety and Outcomes of Oral Graded Challenges to Amoxicillin without Prior Skin Testing. J Allergy Clin Immunol Pract. 2019 Jan;7(1):236-243. doi: 10.1016/j.jaip.2018.05.008. Epub 2018 May 23.
PubMed 29802906Ibanez MD, Rodriguez Del Rio P, Lasa EM, Joral A, Ruiz-Hornillos J, Munoz C, Gomez Traseira C, Escudero C, Olaguibel Rivera JM, Garriga-Baraut T, Gonzalez-de-Olano D, Rosado A, Sanchez-Garcia S, Perez Bustamante S, Padial Vilchez MA, Prieto Montano P, Candon Morillo R, Macias Iglesia E, Feliu Vila A, Valbuena T, Lopez-Patino A, Martorell A, Sastre J, Audicana MT; Penicillin Allergy in Children (APENIN) Task Force. Pediatric Allergy Committee, Spanish Society of Allergy and Clinical Immunology (SEAIC). Prospective assessment of diagnostic tests for pediatric penicillin allergy: From clinical history to challenge tests. Ann Allergy Asthma Immunol. 2018 Aug;121(2):235-244.e3. doi: 10.1016/j.anai.2018.05.013. Epub 2018 May 25.
PubMed 29803713Confino-Cohen R, Rosman Y, Meir-Shafrir K, Stauber T, Lachover-Roth I, Hershko A, Goldberg A. Oral Challenge without Skin Testing Safely Excludes Clinically Significant Delayed-Onset Penicillin Hypersensitivity. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):669-675. doi: 10.1016/j.jaip.2017.02.023.
PubMed 28483317Banks TA, Tucker M, Macy E. Evaluating Penicillin Allergies Without Skin Testing. Curr Allergy Asthma Rep. 2019 Mar 22;19(5):27. doi: 10.1007/s11882-019-0854-6.
PubMed 30903298
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04408508
- Acronym / sponsor ID
- REB-19-97
- Conditions
- Penicillin Allergy
- Keywords
- beta-lactam, penicillin, hypersensitivity, drug allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 May 2020 (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.
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, less than 5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship.
There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Direct oral amoxicillin challenges are safe and effective in delabeling low risk patients who report penicillin allergy in large paediatric and adult studies and does not necessitate specialist referral.
The study team seeks to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). The study investigators will determine the number of patients successfully delabelled of their "penicillin allergy" prior to discharge from hospital over a 12 month period. The study doctors will also assess the economic impact of the investigator's model and ease of implementation in the busy inpatient setting. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabelled.
Detailed description
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, only <5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship. There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Consequently, patients with a penicillin allergy label receive alternative antibiotics such as carbapenems, fluoroquinolones, and vancomycin for the treatment of common and serious infections and for pre-surgical prophylaxis. Patients with penicillin allergy label have longer hospital stays and higher rates of infections with Clostridioides (Clostridium) difficile, VRE and MRSA in comparison with patients without a documented allergy.
Direct oral amoxicillin challenges are safe and effective in delabeling patients stratified as low risk for penicillin allergy in large pediatric and adult studies. Low-risk penicillin allergy histories include patients who have had isolated nonallergic symptoms (eg, gastrointestinal symptoms) or patients solely with a family history of a penicillin allergy, pruritus without rash, or remote (>10 years) unknown reactions without features suggestive of an IgE-mediated reaction.
The study investigators seek to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). Identified patients that fulfill the exclusion and inclusion criteria will be reviewed at the time of discharge for suitability, as per the algorithm, modelled after a previous study of similar design. Based on patient's reported allergy, and upon obtaining informed consent, participants will receive a supervised challenge of amoxicillin 250 mg once orally and subsequently observed for 1 hour before discharge home. After antibiotic challenge, patient outcome will be defined as (1) tolerated oral challenge with no adverse drug reaction or (2) adverse drug reaction.
By challenging carefully selected low risk patient that are unlikely to be truly allergic while in hospital, the study doctors can delabel patients of their "penicillin allergy" and as a result cut health care expenditures and promote good antimicrobial stewardship. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabeled.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients reporting penicillin allergy will be enrolled based on eligibility criteria for direct oral amoxicillin challenge. There will be one treatment group of patients assigned low risk for penicillin allergy.
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin administration | Other | Drug: Amoxicillin 250 MGOral amoxicillin administered to study patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Assessed to be low risk of having a penicillin allergy as per the risk stratification questionnaire
- One of the following: i) An unknown reaction >10 years before, ii) A type A adverse drug reaction (pharmacologically predictable drug side effect or intolerance), or iii) A history of a benign childhood rash, nonurticarial rash, or maculopapular exanthem more than 10 years ago
- Age 18 years or older
- Hemodynamically stable and suitable for discharge home
Key exclusion criteria (9 listed)
- Declines participation in the study
- Cognitive impairment and where a collateral history could not be obtained
- History of anaphylaxis or angioedema attributed to a penicillin-based antibiotic
- History of severe cutaneous adverse reactions attributed to a penicillin-based antibiotic
- History of acute kidney injury or severe liver impairment attributed to a penicillin-based antibiotic
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 |
|---|---|---|
| Amoxicillin 250 MGAlso: Amoxicillin 250 mg CapsuleLow dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria. | Drug | Amoxicillin administration |
Primary outcome
Number of patients tolerating oral amoxicillin challenge
Time frame: 12 months
The number of patients tolerating a single dose oral amoxicillin (250 mg) challenge without adverse reaction(s) up to one hour of administration
4 secondary outcomes
Number of patients reporting a delayed reaction to amoxicillin
Time frame: 12 months
Average delay in discharge attributable to amoxicillin challenge
Time frame: 12 months
The number of patients excluded from the study due to staff time constraints
Time frame: 12 months
Type of immediate reaction attributed to the oral amoxicillin: maculopapular rash, urticaria, angioedema, airway compromise, diarrhea, vomiting or other (including subjective symptoms)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 20934625Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.
- Results publication: PubMed 26110680Macy E. Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs. Curr Opin Allergy Clin Immunol. 2015 Aug;15(4):308-13. doi: 10.1097/ACI.0000000000000173.
- Results publication: PubMed 24565482Macy E, Ngor EW. Safely diagnosing clinically significant penicillin allergy using only penicilloyl-poly-lysine, penicillin, and oral amoxicillin. J Allergy Clin Immunol Pract. 2013 May-Jun;1(3):258-63. doi: 10.1016/j.jaip.2013.02.002. Epub 2013 Apr 6.
- Results publication: PubMed 29883754Mohamed OE, Beck S, Huissoon A, Melchior C, Heslegrave J, Baretto R, Ekbote A, Krishna MT. A Retrospective Critical Analysis and Risk Stratification of Penicillin Allergy Delabeling in a UK Specialist Regional Allergy Service. J Allergy Clin Immunol Pract. 2019 Jan;7(1):251-258. doi: 10.1016/j.jaip.2018.05.025. Epub 2018 Jun 5.
- Results publication: PubMed 24188976Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.
- Results publication: PubMed 27043788Mill C, Primeau MN, Medoff E, Lejtenyi C, O'Keefe A, Netchiporouk E, Dery A, Ben-Shoshan M. Assessing the Diagnostic Properties of a Graded Oral Provocation Challenge for the Diagnosis of Immediate and Nonimmediate Reactions to Amoxicillin in Children. JAMA Pediatr. 2016 Jun 6;170(6):e160033. doi: 10.1001/jamapediatrics.2016.0033. Epub 2016 Jun 6.
- Results publication: PubMed 28341170Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):813-815. doi: 10.1016/j.jaip.2017.01.023. Epub 2017 Mar 21. No abstract available.
- Results publication: PubMed 29425903Labrosse R, Paradis L, Lacombe-Barrios J, Samaan K, Graham F, Paradis J, Begin P, Des Roches A. Efficacy and Safety of 5-Day Challenge for the Evaluation of Nonsevere Amoxicillin Allergy in Children. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1673-1680. doi: 10.1016/j.jaip.2018.01.030. Epub 2018 Feb 7.
- Results publication: PubMed 29802906Iammatteo M, Alvarez Arango S, Ferastraoaru D, Akbar N, Lee AY, Cohen HW, Jerschow E. Safety and Outcomes of Oral Graded Challenges to Amoxicillin without Prior Skin Testing. J Allergy Clin Immunol Pract. 2019 Jan;7(1):236-243. doi: 10.1016/j.jaip.2018.05.008. Epub 2018 May 23.
- Results publication: PubMed 29803713Ibanez MD, Rodriguez Del Rio P, Lasa EM, Joral A, Ruiz-Hornillos J, Munoz C, Gomez Traseira C, Escudero C, Olaguibel Rivera JM, Garriga-Baraut T, Gonzalez-de-Olano D, Rosado A, Sanchez-Garcia S, Perez Bustamante S, Padial Vilchez MA, Prieto Montano P, Candon Morillo R, Macias Iglesia E, Feliu Vila A, Valbuena T, Lopez-Patino A, Martorell A, Sastre J, Audicana MT; Penicillin Allergy in Children (APENIN) Task Force. Pediatric Allergy Committee, Spanish Society of Allergy and Clinical Immunology (SEAIC). Prospective assessment of diagnostic tests for pediatric penicillin allergy: From clinical history to challenge tests. Ann Allergy Asthma Immunol. 2018 Aug;121(2):235-244.e3. doi: 10.1016/j.anai.2018.05.013. Epub 2018 May 25.
- Results publication: PubMed 28483317Confino-Cohen R, Rosman Y, Meir-Shafrir K, Stauber T, Lachover-Roth I, Hershko A, Goldberg A. Oral Challenge without Skin Testing Safely Excludes Clinically Significant Delayed-Onset Penicillin Hypersensitivity. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):669-675. doi: 10.1016/j.jaip.2017.02.023.
- Results publication: PubMed 30903298Banks TA, Tucker M, Macy E. Evaluating Penicillin Allergies Without Skin Testing. Curr Allergy Asthma Rep. 2019 Mar 22;19(5):27. doi: 10.1007/s11882-019-0854-6.
- Individual participant dataSharing planned: No. No only agregate data will be shared
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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.
Andrea Fong, MD, FRCPC principal investigator
Saskatchewan Health Authority - Regina Area
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin 250 MG in people with Penicillin Allergy, run by Saskatchewan Health Authority - Regina Area.
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 4 inclusion and 9 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Sarah Lohrenz, MD (13067156011, skl621@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients tolerating oral amoxicillin challenge (time frame: 12 months). 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 NCT04408508, which also lists 12 linked publications.
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 13 Apr 2023.