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Clinical Trials/EUCTR2019-002592-34-GB
EUCTR2019-002592-34-GB
Active, Not Recruiting
Phase 1

Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Diagnostics (RID-TB:Dx)A randomised controlled trial to evaluate the effectiveness of using the RD-1 based C Tb skin test as a replacement for blood-based interferon-? release assay for detection of latent TB infection and initiation of TB preventive treatment in the UK - RID-TB:Dx

niversity College London0 sites1,705 target enrollmentFebruary 10, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity College London
Enrollment
1705
Status
Active, Not Recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 10, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity College London

Eligibility 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

  • •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
  • •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

Outcomes

Primary Outcomes

Not specified

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