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Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

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ClinicalTrials.gov Identifier: NCT05989802
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : January 31, 2024
Sponsor:
Collaborators:
Instituto Nacional de Saúde, Mozambique
National Referral Hospital
University of Cape Town
Johns Hopkins University
Elizabeth Glaser Pediatric AIDS Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, Irvine
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.

Condition or disease Intervention/treatment Phase
Tuberculosis Diagnostics Global Health Diagnostic Test: Oral swab molecular testing Diagnostic Test: Automated Cough Sound Analysis Diagnostic Test: Automated Lung Sound Analysis Other: Chest X Ray Computer Aided Detection Not Applicable

Detailed Description:
The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies will rigorously assess promising, point-of-care (POC) TB diagnostic tests in clinical studies conducted among children at settings of intended use. There is an urgent need for novel tests for TB diagnosis in children under 15 years because of the challenge of obtaining sputum samples from children and the low sputum bacillary burden among children with TB even when a sample is obtained. This creates delays in diagnosis and treatment initiation, and is a major contributor to the 230,000 childhood deaths from TB each year. Therefore, a non-sputum biomarker-based test has been ranked among the highest priority target product profiles for new TB diagnostics. If inexpensive and simple to perform, such a diagnostic tool could have significant impact by facilitating rapid diagnosis and TB treatment in children. The studies will evaluate the sensitivity and specificity of novel diagnostic tests in children in reference to NIH consensus definitions for childhood TB. In addition, the usability and acceptability of the novel TB diagnostic tests will be assessed through direct observations and surveys of routine health workers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rapid Research in Diagnostics Development for Tuberculosis Network (R2D2 Kids) and Assessing Diagnostics At Point-of-care for Tuberculosis in Children (ADAPT for Kids)
Actual Study Start Date : January 26, 2024
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : September 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Evaluation of various novel TB triage and diagnostic tests
The investigators will conduct evaluation of novel TB triage and diagnostic tests in a cohort of children with presumed TB. The investigators aim to enroll 250 participants per year at each of three enrollment sites for evaluation of various novel TB triage and diagnostic tests and 30 health workers to assess test usability. Novel test evaluations will be conducted on a rolling basis as new tests ready for field evaluation are identified.
 Diagnostic Test: Oral swab molecular testing
Swab-based testing provides a non-invasive approach to collect respiratory specimens for TB testing. Data in adults suggests that swab-based testing could be valuable when sputum collection is not feasible or available.

Diagnostic Test: Automated Cough Sound Analysis
Cough sounds can be collected through a mobile phone and tablet, and then analyzed with machine learning algorithms to predict TB.

Diagnostic Test: Automated Lung Sound Analysis
Lung sounds can be collected with a non-invasive digital stethoscope, and then saved on a tablet or phone and analyzed by machine learning algorithms to predict TB.

Other: Chest X Ray Computer Aided Detection
Several artificial intelligence algorithms have been developed to predict TB, though this has not yet been validated in children.
Other Name: Artificial Intelligence algorithm


Outcome Measures
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Primary Outcome Measures :
  1. Proportion with positive index test result among participants with tuberculosis (TB) [ Time Frame: 2 years ]
    Sensitivity - Number with positive index test result/(Number with positive or negative index t test result) among participants with TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)

  2. Proportion with negative index test result among participants without tuberculosis (TB) [ Time Frame: 2 years ]
    Specificity - Number with negative index test results/(Number with positive or negative index t test result) among participants without TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Participant eligibility criteria:

Participants will include children (age <15 years) who present to care with:

A. 2 or more of the following:

  • Unexplained cough for any duration
  • TB contact or tuberculin skin test or interferon gamma release assay positive
  • Abnormal chest X-ray (any abnormality) OR

B. Any one of criteria A AND any one of the following:

  • Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition
  • Unexplained fever ≥2 weeks
  • Unexplained lethargy or reduced playfulness ≥2 weeks

The study will exclude participants who:

  1. Completed preventive 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 for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);
  3. Are unable to return for follow-up visits; or
  4. Whose parents/guardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB)

Assessment of the usability of novel TB tests:

The study will also 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). Personnel who are unwilling to provide informed consent will be excluded.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989802


Contacts
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Contact: Devan Jaganath, MD 415-514-4692 devan.jaganath@ucsf.edu
Contact: Brittney Sweetser, MPH bsweetse@hs.uci.edu

Locations
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Mozambique
Instituto Nacional de Saúde Recruiting
Maputo, Mozambique
Contact: Celso Khosa       celso.khosa@ins.gov.mz   
South Africa
Dora Nginza Hospital Not yet recruiting
Cape Town, South Africa
Contact: Heather Zar       heather.zar@uct.ac.za   
Uganda
Mulago National Referral Hospital Not yet recruiting
Kampala, Uganda
Contact: Eric Wobudeya       ewobudeya@mujhu.org   
Sponsors and Collaborators
University of California, San Francisco
Instituto Nacional de Saúde, Mozambique
National Referral Hospital
University of Cape Town
Johns Hopkins University
Elizabeth Glaser Pediatric AIDS Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, Irvine
Investigators
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Principal Investigator: Adithya Cattamanchi, MD, MAS University of California, Irvine
Principal Investigator: Nilesh Bhatt Elizabeth Glazer Pediatric AIDS Foundation
More Information
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Publications:
World Health Organization. Roadmap towards ending TB in children and adolescents. Geneva: World Health Organization, 2018. Available at: https://www.who.int/tb/publications/2018/tb-childhoodroadmap/en/. Last accessed 1 June 2022.
WHO. High-priority target product profiles for new tuberculosis diagnostics: Report of a consensus meeting. Geneva, Switzerland. Available at: http://www.who.int/tb/publications/tpp_report/en/, 2014.
World Health Organization. Global Tuberculosis Report 2021. Geneva: World Health Organization, 2021.
World Health Organization. Roadmap towards ending TB in children and adolescents. Geneva: World Health Organization, 2018.
World Health Organization. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Available at: http://apps.who.int/iris/bitstream/handle/10665/135617/WHO_HTM_TB_2014.18_eng.pdf?sequence=12014.
UCSF Human Research Protection Program. The Level of Review and Minimal Risk. Available at: https://irb.ucsf.edu/levels-review#Category-2-Blood-sampling-limited-amounts. Last accessed 4 Jan 2023.

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05989802    
Other Study ID Numbers: R01HL169449 ( U.S. NIH Grant/Contract )
U01AI152087 ( U.S. NIH Grant/Contract )
7200AA22RFA00004 ( Other Grant/Funding Number: USAID )
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections