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RECRUITINGINTERVENTIONAL

Rapid Research in Diagnostics Development for TB Network

Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 willing to sign a consent form Assessment of the usability of novel TB tests: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

Novel mycobacterial culture techniques

We will evaluate tests intended to make culture more sensitive, faster, and have less contamination.

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Novel sputum smear microscopy techniques

We will evaluate new staining techniques or visualization methods to increase the sensitivity of smear microscopy.

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Sputum-based molecular assays

We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.

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Tongue swab-based molecular assays

We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.

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Urine LAM assays

We will evaluate urine LAM assays incorporating techniques such as analyte concentration, higher sensitivity or specificity antibodies, or enhanced visualization to improve LAM detection.

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Blood-based host immune response assays

We will evaluate assays measuring host immune response parameters intended for use at near point of care or point of care.

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Breath-based assays

We will evaluate assays assessing volatile organic compounds or exhaled breath condensate for near point of care of point of care detection of TB.

DIAGNOSTIC_TEST

Artificial intelligence-based digital health tools

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).

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Phage-based assays

We will evaluate assays using phages to lyse mycobacterial cells for detection of DNA or antigens.

DIAGNOSTIC_TEST

Cartridge-based molecular assays for detecting drug resistance

We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.

DIAGNOSTIC_TEST

Sequencing-based assays for detecting drug resistance

We will evaluate targeted and whole genome sequencing assays.

Locations (16)

National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia
Chitoor (Christian Medical College satellite campus)
Vellore, India
Christian Medical College CMC Pulmonary Outpatient Department
Vellore, India
Primary care clinics (Shalom/LCC, CHAD)
Vellore, India
Zankli Research Center
Abuja, Nigeria
De La Salle Medical and Health Sciences Institute
Dasmariñas, Philippines
Brooklyn Chest Hospital
Cape Town, South Africa
Khayelitsha District Health Center
Cape Town, South Africa
Kraaifontein Community Health Clinic
Cape Town, South Africa
Scottsdene primary care clinic
Cape Town, South Africa
Wallacedene primary care clinic
Cape Town, South Africa
Kisenyi Health Center
Kampala, Uganda
Mulago Outpatient Department
Kampala, Uganda
Hanoi Lung Hospital, Outpatient departments
Hanoi, Vietnam
National Lung Hospital, Outpatient departments
Hanoi, Vietnam
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia