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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Georgia
National Center for Tuberculosis and Lung Diseases
RECRUITING
Tbilisi
India
Chitoor (Christian Medical College satellite campus)
RECRUITING
Vellore
Christian Medical College CMC Pulmonary Outpatient Department
RECRUITING
Vellore
Primary care clinics (Shalom/LCC, CHAD)
RECRUITING
Vellore
Nigeria
Zankli Research Center
RECRUITING
Abuja
Philippines
De La Salle Medical and Health Sciences Institute
RECRUITING
Dasmariñas
South Africa
Brooklyn Chest Hospital
RECRUITING
Cape Town
Khayelitsha District Health Center
RECRUITING
Cape Town
Kraaifontein Community Health Clinic
RECRUITING
Cape Town
Scottsdene primary care clinic
RECRUITING
Cape Town
Wallacedene primary care clinic
RECRUITING
Cape Town
Uganda
Kisenyi Health Center
RECRUITING
Kampala
Mulago Outpatient Department
RECRUITING
Kampala
Viet Nam
Hanoi Lung Hospital, Outpatient departments
RECRUITING
Hanoi
National Lung Hospital, Outpatient departments
RECRUITING
Hanoi
Zambia
Centre for Infectious Disease Research in Zambia
RECRUITING
Lusaka
Contact Information
Primary
Adithya Cattamanchi, MD
adithya.cattamanchi@ucsf.edu
+1-415-206-5489
Backup
Catherine Cook, MPH
catherine.cook@ucsf.edu
603-988-9940
Time Frame
Start Date: 2021-04-14
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 26436
Treatments
Experimental: Evaluation of various novel TB triage and diagnostic tests.
For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB, with nested feasibility/pilot studies of early and late prototype tests. The investigators aim to enroll 300-450 participants per year at each of five enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability.
Experimental: Evaluation of novel rDST assays
Clinicians at participating sites will be asked to refer adult patients with rifampin-resistance identified by routine molecular testing. The investigators aim to enroll 100-200 patients per year at each of three enrollment sites for evaluation of novel rDST assays.
Related Therapeutic Areas
Sponsors
Collaborators: Makerere University, Johns Hopkins Bloomberg School of Public Health, Federal University of Mato Grosso, Stanford University, Medical Research Council, De La Salle University Medical Center, University of California, Irvine, Vietnam National Lung Hospital, Zankli Research Center, National Institute of Allergy and Infectious Diseases (NIAID), Christian Medical College, Vellore, India, University of Stellenbosch, Socios En Salud Sucursal, Peru, Johns Hopkins University, National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia, Centre for Infectious Disease Research in Zambia, Harvard Medical School (HMS and HSDM), Foundation for Innovative New Diagnostics, Switzerland, University Hospital Heidelberg
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov