Development of Diagnostic Pathway for Teicoplanin Allergy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hypersensitivity

Clinical Trial Details

NCT number	NCT03210233
Study type	Interventional
Source	The Leeds Teaching Hospitals NHS Trust
Contact	Louise Savic, MBBS MRCP FRCA
Phone	+44 113 243 3144
Email	louise.savic@nhs.net
Status	Recruiting
Phase	N/A
Start date	March 1, 2017
Completion date	May 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.