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NCT Number: NCT06803758

Teicoplanin Allergy Testing Using Autologous Serum (TATAS)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location status: Recruiting

Location contact

Efrem Eren

SUB_INVESTIGATOR

Joshua Gladman, MBBS, MRCP (UK)

SUB_INVESTIGATOR

Linda Nel, MB BCh, FRCA

CONTACT

[email protected]

+447957543839

Linda Nel, MB BCh, FRCA

PRINCIPAL_INVESTIGATOR

Louis Young, BA(Hons), BM (Hons), FRCA

SUB_INVESTIGATOR

Xi Ying Soo, MBBS, MRCP (UK)

SUB_INVESTIGATOR

Xi Ying Soo, MBBS, MRCP(UK)

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teicoplanin Allergy Testing using autologous serum

Diagnostic Test

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)

Primary outcomes

  1. Does using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy skin test?

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Nel, MB BCh FRCA

CONTACT

[email protected]

07957543839

Xi Ying Soo, MBBS

CONTACT

[email protected]

023 8077 7222 ext. 6650

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study title

Improving The Sensitivity of Teicoplanin Allergy Testing By Using Autologous Serum

Acronym: TATAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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