HypersensitivityNCT03210233
Development of Diagnostic Pathway for Teicoplanin Allergy
A study testing Blood test, skin testing and challenge testing. in people with Hypersensitivity, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Blood test, skin testing and challenge testing.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All groups >16 years, willing and able to give informed consent.
- Group 1(G1). Naïve controls 72 recruited from staff/students of the University of Leeds (n= >40,000 persons) where infrastructure exists to advertise and rapidly recruit
- >16 years, willing and able to give informed consent
- Never received teicoplanin
- Group 2(G2). "High risk". Received teicoplanin and suffered IgE mediated allergic reaction as defined by our pre-set clinical criteria n=132 to achieve n-119 with complete follow up data, recruited from the "Suspected Anaesthetic Allergy clinic", where patients who have suffered suspected perioperative allergy are referred.
- >16 years, willing and able to give consent
Show all 9Show fewer
- Received teicoplanin and suffered suspected IgE mediated anaphylaxis
- Group 3 (G3). "Low risk". Received teicoplanin without reaction
- G3: n=397 to achieve n=357 with complete follow up data, recruited from surgical areas where teicoplanin is used routinely; predominantly orthopaedic surgery
Who cannot join
- History of antibiotic anaphylaxis/specialist drug allergy testing
- History of toxic epidermal necrolysis or Stevens Johnson syndrome
- Brittle asthma
- Dermographism or other poorly controlled skin condition
- Pregnant, planning to become pregnant during study, breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,
About this study
Official title: Development of a Novel Diagnostic Pathway for Immediate Type Hypersensitivity Reactions to Teicoplanin, Including Invivo and Ex-vivo Testing Modalities.
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.
Read more
Collaborating with our industry partner ThermoFisher (significant expertise in this area), we aim to:
- Standardise the current skin testing protocols being used when testing patients with suspected teicoplanin allergy.
- Develop laboratory tests to support the skin tests, and give a more confident diagnosis to patients.
- Understand how and why people develop allergy to teicoplanin, to better predict and modify the allergic response.
- Conditions
- Hypersensitivity
- Being tested
- Blood test, skin testing and challenge testing.
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test, skin testing and challenge testing.Procedure or surgery
Skin Prick Testing (SPT) and Intradermal Testing (IDT). We will follow the STARD framework for reporting studies of diagnostic accuracy
| Study group | Role | What they receive |
|---|---|---|
| Naive controls | Experimental | Never received teicoplanin. Blood test, skin testing and challenge testing. Receives: Procedure: Blood test, skin testing and challenge testing. |
| High Risk | Experimental | Received teicoplanin and suffered suspected IgE mediated anaphylaxis. Blood test, skin testing and challenge testing. Receives: Procedure: Blood test, skin testing and challenge testing. |
| Low Risk | Experimental | Received teicoplanin previously with no adverse reaction Blood test, skin testing and challenge testing. Receives: Procedure: Blood test, skin testing and challenge testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo testing
Skin testing protocols, which identify IgE mediated sensitivity to teicoplanin.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Mar 2017
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210233
- Sponsor's protocol ID
- AN15/424
- Status last verified
- Jul 2019
- First submitted
- 27 Mar 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Diagnostic Pathway for Immediate Type Hypersensitivity Reactions to Teicoplanin, Including Invivo and Ex-vivo Testing Modalities.
- ClinicalTrials.gov ID
- NCT03210233
- Acronym / sponsor ID
- AN15/424
- Conditions
- Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 6 Jul 2017 (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.
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:
- Standardise the current skin testing protocols being used when testing patients with suspected teicoplanin allergy.
- Develop laboratory tests to support the skin tests, and give a more confident diagnosis to patients.
- Understand how and why people develop allergy to teicoplanin, to better predict and modify the allergic response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naive controls | Experimental | Procedure: Blood test, skin testing and challenge testing.Never received teicoplanin. Blood test, skin testing and challenge testing. |
| High Risk | Experimental | Procedure: Blood test, skin testing and challenge testing.Received teicoplanin and suffered suspected IgE mediated anaphylaxis. Blood test, skin testing and challenge testing. |
| Low Risk | Experimental | Procedure: Blood test, skin testing and challenge testing.Received teicoplanin previously with no adverse reaction Blood test, skin testing and challenge testing. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- All groups >16 years, willing and able to give informed consent.
- Group 1(G1). Naïve controls 72 recruited from staff/students of the University of Leeds (n= >40,000 persons) where infrastructure exists to advertise and rapidly recruit
- >16 years, willing and able to give informed consent
- Never received teicoplanin
- Group 2(G2). "High risk". Received teicoplanin and suffered IgE mediated allergic reaction as defined by our pre-set clinical criteria n=132 to achieve n-119 with complete follow up data, recruited from the "Suspected Anaesthetic Allergy clinic", where patients who have suffered suspected perioperative allergy are referred.
Key exclusion criteria (5 listed)
- History of antibiotic anaphylaxis/specialist drug allergy testing
- History of toxic epidermal necrolysis or Stevens Johnson syndrome
- Brittle asthma
- Dermographism or other poorly controlled skin condition
- Pregnant, planning to become pregnant during study, breastfeeding
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 |
|---|---|---|
| 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 | Procedure or surgery | High Risk, Low Risk, Naive controls |
Primary outcome
In vivo testing
Time frame: 12 months
Skin testing protocols, which identify IgE mediated sensitivity to teicoplanin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test, skin testing and challenge testing. in people with Hypersensitivity, run by The Leeds Teaching Hospitals NHS 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 9 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Savic, MBBS MRCP FRCA (+44 113 243 3144, louise.savic@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo testing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019.