NCT04923958 Rapid Research in Diagnostics Development for TB Network
| NCT ID | NCT04923958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 26,436 participants |
| Start Date | 2021-04-14 |
| Primary Completion | 2031-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26,436 participants in total. It began in 2021-04-14 with a primary completion date of 2031-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Adithya Cattamanchi, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT04923958 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04923958 currently recruiting?
Yes, NCT04923958 is actively recruiting participants. Contact the research team at adithya.cattamanchi@ucsf.edu for enrollment information.
Where is the NCT04923958 trial being conducted?
This trial is being conducted at Tbilisi, Georgia, Vellore, India, Vellore, India, Vellore, India and 11 additional locations.
Who is sponsoring the NCT04923958 clinical trial?
NCT04923958 is sponsored by University of California, San Francisco. The principal investigator is Adithya Cattamanchi, MD at University of California, San Francisco. The trial plans to enroll 26,436 participants.