Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Diagnostics (RID TB:Dx)A randomised trial to evaluate the effectiveness of a new C-Tb skin test to replace the current IGRA blood test for diagnosing latent TB infectio

Phase 1

• Conditions: atent Tuberculosis infection (LTBI); MedDRA version: 20.0Level: PTClassification code 10065048Term: Latent tuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002592-34-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-10
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1705

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified