Teicoplanin Allergy Testing Using Autologous Serum (TATAS) (TATAS)

Improving the Sensitivity of Teicoplanin Allergy Testing by Using Autologous Serum

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.

Study Overview

• Status: Recruiting
• Conditions: Drug Allergy
• Intervention / Treatment: Diagnostic test: Teicoplanin Allergy Testing using autologous serum

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Nel, MB BCh FRCA; Phone Number: 07957543839; Email: linda.nel@uhs.nhs.uk
• Study Contact Backup: Name: Xi Ying Soo, MBBS; Phone Number: 6650 023 8077 7222; Email: xi.soo@uhs.nhs.uk

Study Locations

• United Kingdom
  • Southampton, United Kingdom, so16 6yd
    • Recruiting
    • University Hospital Southampton
    • Contact: Linda Nel, MB BCh, FRCA; Phone Number: +447957543839; Email: linda.nel@uhs.nhs.uk
    • Contact: Xi Ying Soo, MBBS, MRCP(UK); Email: xi.soo@uhs.nhs.uk
    • Contact: Linda Nel, MB BCh, FRCA
    • Contact: Xi Ying Soo, MBBS, MRCP (UK)
    • Contact: Louis Young, BA(Hons), BM (Hons), FRCA
    • Contact: Joshua Gladman, MBBS, MRCP (UK)
    • Contact: Efrem Eren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Teicoplanin allergy testing using autologous serum; 20 adult patients with history of anaphylaxis under anaesthesia ( the index episode), where teicoplanin has been given during the index episode will be recruited. In addition to usual skin testing with Teicoplanin directly onto the skin, we will perform skin testing with Teicoplanin- added autologous serum. The trial will be conducted as part of the same routine elective allergy skin-testing appointment for other drugs given during the index episode.

Diagnostic test: Teicoplanin Allergy Testing using autologous serum; In addition to performing teicoplanin allergy skin testing using standard recommended Teicoplanin concentration, we will perform skin testing using autologous serum, the supernatant which is obtained via centrifugation. Skin testing ( skin prick test and intradermal test) will be performed with these additional samples: STpre: Teicoplanin added to blood sample pre-centrigufation.; STpost: Teicoplanin added to supernatant post-centrigufation.; ST0: Supernatant with no additives ( serum negative control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy skin test?	We will determine if testing using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy test. A positive skin prick test is defined as having wheals of 3x3mm or more at 15 mins. A positive intradermal test results is defined as wheal increment by 3mm in any direction after 20 minutes.	2 years

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Investigators: Study Chair: Linda Nel, MB BCh FRCA, University Hospital Southampton NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Autologous serum skin test reactions in chronic spontaneous urticaria differ from heterologous cell reactions
• BSACI Standard Operating Procedures- Skin Prick Test
• Emergency treatment of anaphylaxis

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Autologous Serum; Teicoplanin allergy testing
• Additional Relevant MeSH Terms: Immune System Diseases; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity; Anti-Bacterial Agents; Anti-Infective Agents; Teicoplanin
• Other Study ID Numbers: RHM CRI0456; 345535 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No