Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03210233
Eligibility Criteria:
Inclusion Criteria:
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
INCLUSION CRITERIA:
* \>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.
INCLUSION CRITERIA:
* \>16 years, willing and able to give consent
* 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
Exclusion Criteria:
EXCLUSION CRITERIA for G1, G2 and G3.
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
100 Years
Study:
NCT03210233
Study Brief:
Protocol Section:
NCT03210233