Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients

NCT04408508 | Unknown

• 1 other identifier: REB-19-97
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Penicillin Allergy

Keywords

beta-lactam; penicillin; hypersensitivity; drug allergy

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Number of patients reporting a delayed reaction to amoxicillin

  12 months

• Average delay in discharge attributable to amoxicillin challenge

  12 months

• The number of patients excluded from the study due to staff time constraints

  12 months

• Type of immediate reaction attributed to the oral amoxicillin: maculopapular rash, urticaria, angioedema, airway compromise, diarrhea, vomiting or other (including subjective symptoms)

  12 months

Study Arms (1)

Amoxicillin administration

OTHER

Oral amoxicillin administered to study patients

Drug: Amoxicillin 250 MG

Interventions

Amoxicillin 250 MG DRUG

Low dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria.

Also known as: Amoxicillin 250 mg Capsule

Amoxicillin administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Hemodynamically unstable
• History of idiopathic urticaria or idiopathic anaphylaxis
• Currently taking an antibiotic(s) for treatment of an active infection

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead

Related Publications (12)

• 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.

  PMID: 20934625 BACKGROUND

• Macy 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.

  PMID: 26110680 RESULT

• Macy 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.

  PMID: 24565482 RESULT

• Mohamed 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.

  PMID: 29883754 RESULT

• Macy 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.

  PMID: 24188976 RESULT

• Mill 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.

  PMID: 27043788 RESULT

• Tucker 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.

  PMID: 28341170 RESULT

• Labrosse 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.

  PMID: 29425903 RESULT

• Iammatteo 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.

  PMID: 29802906 RESULT

• Ibanez 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.

  PMID: 29803713 RESULT

• Confino-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.

  PMID: 28483317 RESULT

• Banks 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.

  PMID: 30903298 RESULT

MeSH Terms

Conditions

Hypersensitivity; Drug Hypersensitivity

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrea Fong, MD, FRCPC

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Lohrenz, MD

CONTACT

13067156011; skl621@usask.ca

Andrea Fong, MD, FRCPC

CONTACT

13062061291; andrea.fong@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: May 29, 2020
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share