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Development of Diagnostic Pathway for Teicoplanin Allergy

NCT03210233 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2019-07-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210233 on ClinicalTrials.gov