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Completed

NCT Number: NCT03607734

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

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.

Primary outcomes

  1. Completion of the study questionnaire by participants

    Time frame: 1 day

    Online questionnaire about previously diagnosed allergies to be completed by study participants

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Official study title

Penicillin Allergy De-Labelling in Elective Surgical Patients - A Study to Determine the Safety, Efficacy and Feasibility of Abbreviated Allergy Testing

Acronym: PADLES

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2018
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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