Rapid Research in Diagnostics Development for TB Network

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jun 7, 2021

Keywords

ClinConnect Summary

The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) is a clinical trial aimed at improving how we diagnose tuberculosis (TB), a serious lung disease that affects millions of people worldwide. Each year, over 3 million people with TB go undiagnosed, leading to many deaths. This trial seeks to develop new tests that are quicker, simpler, and more affordable, making it easier for healthcare providers to identify TB early and start treatment.

To participate in this trial, adults aged 12 and older may be eligible if they have a cough lasting more than two weeks or if they have specific risk factors for TB, such as being HIV positive or having a history of close contact with someone who has TB. Participants will undergo screening tests to confirm if they have TB. Healthcare workers involved in TB testing may also join the study to help evaluate these new diagnostic methods. Those who participate can expect to provide samples for testing and attend follow-up appointments. It's important to know that individuals who have recently completed TB treatment or taken certain medications may not qualify for the study. This trial is currently recruiting participants from various countries to help fight TB more effectively.

Gender

ALL

Eligibility criteria

• Novel TB triage and diagnostic tests:
• We will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
• Positive TB screening definitions by risk factor:
• • 1. PLHIV (Risk Factor), CRP \>5 mg/dL OR abnormal CXR (Positive TB screening definition)
• • 2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)
• • 3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)
• We will exclude people who:
• • 1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
• • 2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
• • 3. reside \>20km from the study site or are unwilling to return for follow-up visits; or
• • 4. are unwilling to provide informed consent
• Novel TB rDST assays:
• We will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB/RIF, Xpert MTB/RIF Ultra, or Hain MTBDRplus). We will exclude people who:
• • 1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures
• • 2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment
• • 3. are unable or unwilling to provide informed consent
• Assessment of the usability of novel TB tests:
• • We will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.