Latent Tuberculosis infection (LTBI) MedDRA version: 20.0 Level: PT Classification code 10065048 Term: Latent tuberculosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: C-Tb
Product Code: N/A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rdESAT-6
Other descriptive name: rdESAT-6
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =16 years 2. Eligible for LTBI testing with IGRA and treatment for LTBI according to UK guidance 3. Willing and able to provide written informed consent 4. Willing and able to comply with the trial, including the randomised test(s) and adherence to follow up visits Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1705 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Allergy to C-Tb product or any of its constituents 2. Displaying any symptoms or signs of active TB disease: Unexplained fever; Cough (more than three weeks); Haemoptysis (Blood in sputum); Unexplained weight loss; Drenching night sweats; Lymph node swelling 3. Women who are breastfeeding, pregnant or plan to become pregnant during the study 4. Women of childbearing potential not using contraception A woman of child bearing potential (WOCBP): 12 years of age or older having had their first menstruation and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Effective contraception includes barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study hypothesis is that using new C-Tb skin test for the diagnosis and subsequent management of Latent Tuberculosis Infection (LTBI) will be as good as the current standard-of-care IGRA blood test. This will be evaluated based on the number of participants who then accept and start treatment for LTBI, based on a positive C-Tb test result (intervention arm) or IGRA test result (control arm). ;Secondary Objective: We will be looking at factors that impact on the LTBI testing pathway, and whether C-Tb skin test can replace the current IGRA blood test. This will include: - How many people agree to start treatment for LTBI, and whether there is a difference in this between the two tests. - How many people are lost to follow up (do not attend appointments) between LTBI diagnosis and starting treatment, and whether there is a difference in this between the two tests. - Whether people who do not come back to the clinic to have their C-Tb test read 2-3 days later. Tests assessed outside this timeframe do not give a valid result. - Whether there are any delays in starting treatment, and whether these are different depending on what test was used. - How many people finished their course of LTBI treatment, and whether these are different depending on what test was used. We will also be looking at participant safety, including local and systemic (whole body) reactions to the tests. ;Primary end point(s): The proportion of participants who have positive test results and initiate LTBI treatment ;Timepoint(s) of evaluation of this end point: All participants will reach the end of diagnostic follow up 24 weeks after randomisation. At this point treatment initiation will be confirmed for those who tested positive for LTBI. However, participants may initiate treatment sooner than this which will be at the point of prescription dispensing and collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Related to impact on the LTBI pathway process outcomes: i) Acceptance of LTBI treatment among participants with test positive results in each arm ii) Losses to follow up (default rate) between diagnosis with LTBI and starting treatment iii) Proportion of participants randomised to C Tb that fail to return for C Tb reading in 48-72hrs iv) Delay in starting preventative therapy from testing v) Proportion of participants completing LTBI treatment 2) Safety i) Local and systemic reactions ;Timepoint(s) of evaluation of this end point: i) at the point of prescription dispensing and collection, and at week 24 if applicable ii) At the point of visit non-attendance, and at week 24 iii) At the scheduled day 2-3 visit iv) At the point of prescription dispensing and collection. v) At week 24 2) Safety i) At each attended visit (day 2-3 for C-Tb arm, and week 4/week 24/any unscheduled visit(s) for all participants) | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Manager
MRC Clinical Trials Unit at UCL
Outcome results
None listed