Improving tuberculosis diagnosis through innovative testing methods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) aims to enhance tuberculosis (TB) diagnosis by evaluating new triage and diagnostic tests in real-world settings. This initiative brings together experts from various fields to assess the effectiveness of novel tests designed to quickly identify TB and drug resistance. The study focuses on developing point-of-care tests that can be used by frontline health workers, thereby addressing the significant diagnostic gap that leaves millions undiagnosed. By comparing these new tests against established standards, the study seeks to improve patient outcomes and reduce TB transmission globally.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Center for Tuberculosis and Lung Diseases
  Tbilisi, Georgia Recruiting
• Chitoor (Christian Medical College satellite campus)
  Vellore, India Recruiting
• Christian Medical College CMC Pulmonary Outpatient Department
  Vellore, India Recruiting
• Primary care clinics (Shalom/LCC, CHAD)
  Vellore, India Recruiting
• Zankli Research Center
  Abuja, Nigeria Recruiting
• De La Salle Medical and Health Sciences Institute
  Dasmariñas, Philippines Recruiting

Study contacts

• Principal investigator: Adithya Cattamanchi, MD — University of California, San Francisco
• Study coordinator: Adithya Cattamanchi, MD
• Email: adithya.cattamanchi@ucsf.edu
• Phone: +1-415-206-5489

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Doxycycline added to standard treatment for central nervous system tuberculosis

  This trial tests whether adding doxycycline to standard anti‑TB therapy and corticosteroids helps adults with central nervous system tuberculosis live longer or have less severe neurological disability.

  Recruiting at 5 sites Phase 2 National University Hospital, Singapore · Medan, Medan and 5 other locations · NCT06446245

• Biomarker Test for Diagnosis and Monitoring of Extrapulmonary Tuberculosis

  This study tests biomarker-based methods to help diagnose extrapulmonary TB and monitor treatment in adults, including people living with HIV, using samples from affected sites in Kenya.

  Recruiting at 2 sites Nagasaki University · Nairobi and 1 other locations · NCT07901387

• Short-Course TB Treatment for Children with Non-Severe Pulmonary TB

  This trial tests two shorter-treatment options for kids with non-severe pulmonary TB to see if they can clear the infection as well as the standard 6-month plan.

  Recruiting at 13 sites Phase 2 Huashan Hospital · Fuzhou, Fujian and 12 other locations · NCT07893444

• Combined oral contraceptive timing with Ganfeborole in healthy women

  This study tests how the contraceptive Microgynon behaves in the body when given alone and with Ganfeborole in healthy women who can’t get pregnant.

  Recruiting Phase 1 GlaxoSmithKline · Madrid · NCT07784894

• Isoniazid inhalation in TB patients: a first-in-human look at local tolerability and body levels

  This early study tests inhaled isoniazid to see how well it tolerates the lungs and how it behaves in the body in adults with tuberculosis.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT07708779

• How the immune system responds to mycobacterial infections

  This study tests how the immune system changes in people with tuberculosis and related mycobacterial infections.

  Recruiting First Affiliated Hospital of Ningbo University · Ningbo · NCT07638670

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.