Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-07 @ 5:41 PM
Study NCT ID:
NCT03210233
Status:
UNKNOWN
Last Update Posted:
2019-07-08
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Diagnostic Pathway for Teicoplanin Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D012882', 'term': 'Skin Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 548}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In vivo testing', 'timeFrame': '12 months', 'description': 'Skin testing protocols, which identify IgE mediated sensitivity to teicoplanin.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypersensitivity']}, 'descriptionModule': {'briefSummary': "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.\n\nIt 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.\n\nCollaborating with our industry partner ThermoFisher (significant expertise in this area), we aim to:\n\n1. Standardise the current skin testing protocols being used when testing patients with suspected teicoplanin allergy.\n2. Develop laboratory tests to support the skin tests, and give a more confident diagnosis to patients.\n3. Understand how and why people develop allergy to teicoplanin, to better predict and modify the allergic response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll groups \\>16 years, willing and able to give informed consent.\n\nGroup 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\n\nINCLUSION CRITERIA:\n\n* \\>16 years, willing and able to give informed consent\n* Never received teicoplanin\n\nGroup 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.\n\nINCLUSION CRITERIA:\n\n* \\>16 years, willing and able to give consent\n* Received teicoplanin and suffered suspected IgE mediated anaphylaxis\n\nGroup 3 (G3). "Low risk". Received teicoplanin without reaction\n\nG3: n=397 to achieve n=357 with complete follow up data, recruited from surgical areas where teicoplanin is used routinely; predominantly orthopaedic surgery\n\nExclusion Criteria:\n\nEXCLUSION CRITERIA for G1, G2 and G3.\n\n* History of antibiotic anaphylaxis/specialist drug allergy testing\n* History of toxic epidermal necrolysis or Stevens Johnson syndrome\n* Brittle asthma\n* Dermographism or other poorly controlled skin condition\n* Pregnant, planning to become pregnant during study, breastfeeding'}, 'identificationModule': {'nctId': 'NCT03210233', 'briefTitle': 'Development of Diagnostic Pathway for Teicoplanin Allergy', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'Development of a Novel Diagnostic Pathway for Immediate Type Hypersensitivity Reactions to Teicoplanin, Including Invivo and Ex-vivo Testing Modalities.', 'orgStudyIdInfo': {'id': 'AN15/424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naive controls', 'description': 'Never received teicoplanin. Blood test, skin testing and challenge testing.', 'interventionNames': ['Procedure: Blood test, skin testing and challenge testing.']}, {'type': 'EXPERIMENTAL', 'label': 'High Risk', 'description': 'Received teicoplanin and suffered suspected IgE mediated anaphylaxis. Blood test, skin testing and challenge testing.', 'interventionNames': ['Procedure: Blood test, skin testing and challenge testing.']}, {'type': 'EXPERIMENTAL', 'label': 'Low Risk', 'description': 'Received teicoplanin previously with no adverse reaction Blood test, skin testing and challenge testing.', 'interventionNames': ['Procedure: Blood test, skin testing and challenge testing.']}], 'interventions': [{'name': 'Blood test, skin testing and challenge testing.', 'type': 'PROCEDURE', 'description': 'Skin Prick Testing (SPT) and Intradermal Testing (IDT). We will follow the STARD framework for reporting studies of diagnostic accuracy', 'armGroupLabels': ['High Risk', 'Low Risk', 'Naive controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS1 3HE,', 'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Louise Savic, MBBS MRCP FRCA', 'role': 'CONTACT', 'email': 'louise.savic@nhs.net', 'phone': '+44 113 243 3144'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}