Penicillin Allergy De-Labelling in Elective Surgical Patients (PADLES) (PADLES)

• ClinicalTrials.gov Identifier: NCT03607734
• Recruitment Status: Completed
• First Posted: July 31, 2018
• Last Update Posted: July 31, 2018
• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Information provided by (Responsible Party): The Leeds Teaching Hospitals NHS Trust

Study Description

Brief Summary:

Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug.

The label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. People with the label also have an increased length of hospital stay and rates of readmission. These are significant problems for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. This combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. However in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. Patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already established practice in several centres in Europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the UK.

The aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet NICE criteria for testing.

Condition or disease	Intervention/treatment	Phase
Allergy	Drug: Amoxicillin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Penicillin Allergy De-Labelling in Elective Surgical Patients - A Study to Determine the Safety, Efficacy and Feasibility of Abbreviated Allergy Testing
• Actual Study Start Date: April 24, 2017
• Actual Primary Completion Date: October 2, 2017
• Actual Study Completion Date: October 2, 2017

Arms and Interventions

Arm

Intervention/treatment

Group 1 - Interventional Treatment; A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows: 50mg amoxicillin (10% total dose); 250mg amoxicillin (50% total dose); 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available.

Drug: Amoxicillin; A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows: 50mg amoxicillin (10% total dose); 250mg amoxicillin (50% total dose); 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available.

Outcome Measures

Primary Outcome Measures :

1. Completion of the study questionnaire by participants [ Time Frame: 1 day ]
   Online questionnaire about previously diagnosed allergies to be completed by study participants

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Allergic history is historic (more than 10 years ago) and suggestive of a non-immediate reaction or side effect
• Requires penicillin as first-line treatment for their planned surgery
• >18 years
• Willing and able to give consent

Exclusion Criteria:

• Not willing to participate
• History suggestive of immediate type reaction (anaphylaxis)
• History of toxic epidermal necrolysis or Stevens Johnson syndrome
• Pregnant, planning to become pregnant during study, or breastfeeding

Contacts and Locations

Locations

United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom, LS9 7TF

Sponsors and Collaborators

The Leeds Teaching Hospitals NHS Trust

More Information

• Responsible Party: The Leeds Teaching Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT03607734
• Other Study ID Numbers: AN17/92982
• First Posted: July 31, 2018
• Last Update Posted: July 31, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents