Clinical trial NCT06803758: Teicoplanin Allergy Testing Using Autologous Serum (TATAS)
Official title: Improving The Sensitivity of Teicoplanin Allergy Testing By Using Autologous Serum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Allergy
Keywords: Teicoplanin allergy testing
Autologous Serum
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Allergy testing for Teicoplanin is much more unreliable than for other similar drugs. This means that we run the risk of missing serious Teicoplanin allergy, and these patients will be given another dose in future, not knowing that they are seriously allergic. Serious allergic reactions, also known as anaphylaxis, can be life threatening.

The patients which we recruit to our study will come to us through the perioperative allergy service. They will have had a reaction to a general anaesthetic, but will also have had teicoplanin as part of the anaesthetic.

We are not sure why allergy skin testing, which is fairly reliable for most other drugs, is so unreliable in detecting teicoplanin allergy. We do know that some drugs need to mix with proteins in the blood before they trigger an allergy. We would like to replicate this by mixing the teicoplanin with the patients' own blood and using this for the skin testing, to see if we get a more reliable result compared with the plain drug. Using the patient's own serum to do skin testing is an established test (the 'autologous serum test') used in certain immunological conditions, we are simply going to use it as a vehicle to test our theory.

We will recruit 20 adult patients referred with a recent history of anaphylaxis under anaesthesia, where teicoplanin has been given and is one of the drugs under suspicion of having caused the allergy. In addition to the usual allergy skin testing, which would be done anyway as part of standard allergy investigation, we will perform extra tests using autologous serum for this trial.

We hope to find a better way of testing for Teicoplanin allergy, so that patients are not put at risk where the allergy has been missed because of an unreliable test.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given

Exclusion Criteria:

* Patients unable to stop drugs that would interfere with skin tests prior to study- e.g. antihistamines or certain anti-psychotics
* Pregnancy
* Patients under age 18 years
* Patients with elevated baseline mast cell tryptase requiring further investigation
* Patients with blood-borne viruses such as Hep B, C and HIV

Primary outcomes:
measure: Does using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy skin test?
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Linda Nel, MB BCh FRCA
role: STUDY_CHAIR
References:
citation: Liccardi G, D'Amato G, Canonica GW, Salzillo A, Piccolo A, Passalacqua G. Systemic reactions from skin testing: literature review. J Investig Allergol Clin Immunol. 2006;16(2):75-8.
citation: Savic LC, Garcez T, Hopkins PM, Harper NJ, Savic S. Teicoplanin allergy - an emerging problem in the anaesthetic allergy clinic. Br J Anaesth. 2015 Oct;115(4):595-600. doi: 10.1093/bja/aev307.