Rapid Research in Diagnostics Development for TB Network
Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study
University of California, San Francisco
26,436 participants
Apr 14, 2021
INTERVENTIONAL
Conditions
Summary
To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.
Eligibility
Inclusion Criteria18
- 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:
- PLHIV (Risk Factor), CRP >5 mg/dL OR abnormal CXR (Positive TB screening definition)
- Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)
- History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)
- We will exclude people who:
- completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
- have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
- reside >20km from the study site or are unwilling to return for follow-up visits; or
- 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:
- have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures
- are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment
- 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.
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Interventions
We will evaluate tests intended to make culture more sensitive, faster, and have less contamination.
We will evaluate new staining techniques or visualization methods to increase the sensitivity of smear microscopy.
We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
We will evaluate urine LAM assays incorporating techniques such as analyte concentration, higher sensitivity or specificity antibodies, or enhanced visualization to improve LAM detection.
We will evaluate assays measuring host immune response parameters intended for use at near point of care or point of care.
We will evaluate assays assessing volatile organic compounds or exhaled breath condensate for near point of care of point of care detection of TB.
We will evaluate AI-based algorithms evaluating images (chest x-ray, ultrasound) or sounds (cough sounds, lung sounds) including an Infrasound-to-ultrasound e-stethoscope (Level 42 AI, USA).
We will evaluate assays using phages to lyse mycobacterial cells for detection of DNA or antigens.
We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
We will evaluate targeted and whole genome sequencing assays.
Locations(16)
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NCT04923958