Drug AllergyTATASNCT06803758
Teicoplanin Allergy Testing Using Autologous Serum (TATAS)
A study testing Teicoplanin Allergy Testing using autologous serum in people with Drug Allergy, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Allergy
- What is being tested?
- Teicoplanin Allergy Testing using autologous serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton, SO16 6YD
Linda Nel, MB BCh, FRCA, +447957543839, linda.nel@uhs.nhs.uk
Xi Ying Soo, MBBS, MRCP(UK), xi.soo@uhs.nhs.uk
About this study
Official title: 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.
Read more
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.
- Conditions
- Drug Allergy
- Being tested
- Teicoplanin Allergy Testing using autologous serum
- Keywords
- Teicoplanin allergy testing, Autologous Serum
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teicoplanin Allergy Testing using autologous serumDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Teicoplanin allergy testing using autologous serum | Other | 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. Receives: Diagnostic Test: Teicoplanin Allergy Testing using autologous serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start8 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Nel, MB BCh FRCA, Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803758
- Sponsor's protocol ID
- RHM CRI0456
- Other IDs
- 345535
- Acronym
- TATAS
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16689179Savic 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.
PubMed 26385667
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving The Sensitivity of Teicoplanin Allergy Testing By Using Autologous Serum
- ClinicalTrials.gov ID
- NCT06803758
- Acronym / sponsor ID
- TATAS / RHM CRI0456
- Conditions
- Drug Allergy
- Keywords
- Teicoplanin allergy testing, Autologous Serum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teicoplanin allergy testing using autologous serum | Other | Diagnostic Test: Teicoplanin Allergy Testing using autologous serum20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teicoplanin Allergy Testing using autologous serumIn 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: 1. STpre: Teicoplanin added to blood sample pre-centrigufation. 2. STpost: Teicoplanin added to supernatant post-centrigufation. 3. ST0: Supernatant with no additives ( serum negative control) | Diagnostic test | Teicoplanin allergy testing using autologous serum |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 16689179Liccardi 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.
- Background: PubMed 26385667Savic 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.
- Autologous serum skin test reactions in chronic spontaneous urticaria differ from heterologous cell reactionsLink provided by the sponsor.
- BSACI Standard Operating Procedures- Skin Prick TestLink provided by the sponsor.
- Emergency treatment of anaphylaxisLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Drug Allergy
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Recruiting
Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors
Refractory Tumors, Organoid
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
RecruitingPhase 1
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Nel, MB BCh FRCA study chair
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teicoplanin Allergy Testing using autologous serum in people with Drug Allergy, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Nel, MB BCh FRCA (07957543839, linda.nel@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06803758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.