NCT03210233

Development of Diagnostic Pathway for Teicoplanin Allergy

Development of a Novel Diagnostic Pathway for Immediate Type Hypersensitivity Reactions to Teicoplanin, Including Invivo and Ex-vivo Testing Modalities.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 548 (estimated)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Teicoplanin is an antibiotic used very commonly to prevent infection during surgery. Its use has expanded rapidly in the last few years, with around 18,500 doses administered in Leeds Teaching Hospitals NHS Trust alone, in 2014-15. Unfortunately, anaphylaxis (a severe allergic reaction) to the drug appears to be increasing. These reactions can result in admission to intensive care, prolong hospital stay, or even be fatal. It is vital that patients who suffer anaphylaxis have tests to accurately identify the cause, so they can avoid the drug in future. However these tests are currently very limited, because we don't have any diagnostic tools proven to confirm or refute a diagnosis of teicoplanin allergy. We have to make a 'best guess' diagnosis, leaving patients vulnerable to harm in the future, should they require antibiotics again. We need to reliably diagnose teicoplanin allergy to reduce this arm. Where a diagnosis of teicoplanin allergy is confirmed, patients and their doctors know to avoid it. Importantly, where allergy is excluded, teicoplanin can be safely used, avoiding alternatives that may be less effective, more toxic, and more expensive. This directly benefits individuals, saves the NHS money by reducing avoidable harm, and helps improve antibiotic stewardship at a population level - which in the long term helps reduce antibiotic resistance. The clinical need for this work has become imperative. Collaborating with our industry partner ThermoFisher (significant expertise in this area), we aim to: 1. Standardise the current skin testing protocols being used when testing patients with suspected teicoplanin allergy. 2. Develop laboratory tests to support the skin tests, and give a more confident diagnosis to patients. 3. Understand how and why people develop allergy to teicoplanin, to better predict and modify the allergic response.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
PROCEDURE	Blood test, skin testing and challenge testing.	Skin Prick Testing (SPT) and Intradermal Testing (IDT). We will follow the STARD framework for reporting studies of diagnostic accuracy

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2017-07-06
• Last updated: 2019-07-08

Locations

1 site across 1 country: United Kingdom