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Diagnostics Development for TB screening and management

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092157
Enrollment
8200
Registered
2025-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J984- Other disorders of lung

Interventions

Intervention1: Routine Standard of care TB screening and diagnostic tests: Current diagnostic Gold standard tests like GeneXpert, MGIT culture and Drug sensitivity testing. These tests will be perform

Sponsors

National Institutes of Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: We will include adults and adolescents 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).

Exclusion criteria

Exclusion criteria: We will exclude people whohave 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 or a high-quality specimen with a volume of at least 6 are unable or unwilling to provide informed consent

Design outcomes

Primary

MeasureTime frame
This is expected to improve the participants overall TB care and diagnostics.Timepoint: Cross-sectional study, at TB screening level, which will be the baseline (0 weeks) and Follow-up (2 to 7 monhts)

Secondary

MeasureTime frame
To evaluate new tests to diagnose TB more easily & rapidly & rapid diagnosis.Timepoint: TB screening level (0 weeks), which will be the baseline visit & at follow-up visit (2 to 7 months)

Countries

India, Philippines, South Africa, Uganda, Viet Nam

Contacts

Public ContactBalamugesh Thangakunam

Christian Medical College Vellore

drbalamugesh@cmcvellore.ac.in7907384912

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026