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TuberculosisNCT05989802

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

A study testing Oral swab molecular testing, Automated Cough Sound Analysis and Automated Lung Sound Analysis in people with Tuberculosis and Diagnostics, run by University of California, San Francisco at 3 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages Up to 65 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis, Diagnostics, Global Health
What is being tested?
Oral swab molecular testing, Automated Cough Sound Analysis and Automated Lung Sound Analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,100 participants
Where
3 sitesin 3 countries
Study dates
26 Jan 2024to 1 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Participant eligibility criteria:

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

  1. 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
  1. 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.

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Devan Jaganath, MD contact

415-514-4692

devan.jaganath@ucsf.edu

Brittney Sweetser, MPH contact

bsweetse@hs.uci.edu

3 sites in 3 countries

Mozambique1 site, 1 recruiting

  • Instituto Nacional de Saúde

    Maputo

    Celso Khosa, celso.khosa@ins.gov.mz

    Recruiting

Other trials in Mozambique

South Africa1 site, 1 recruiting

  • Dora Nginza Hospital

    Cape Town

    Heather Zar, heather.zar@uct.ac.za

    Not yet recruiting

Other trials in South Africa

Uganda1 site, 1 recruiting

  • Mulago National Referral Hospital

    Kampala

    Eric Wobudeya, ewobudeya@mujhu.org

    Not yet recruiting

Other trials in Uganda

About this study

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)

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.

Read the 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.

Being tested
Oral swab molecular testing, Automated Cough Sound Analysis, Automated Lung Sound Analysis, Chest X Ray Computer Aided Detection
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral swab molecular testingDiagnostic test

    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.

  • Automated Cough Sound AnalysisDiagnostic test

    Cough sounds can be collected through a mobile phone and tablet, and then analyzed with machine learning algorithms to predict TB.

  • Automated Lung Sound AnalysisDiagnostic test

    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.

  • Chest X Ray Computer Aided DetectionOther

    Also called Artificial Intelligence algorithm

    Several artificial intelligence algorithms have been developed to predict TB, though this has not yet been validated in children.

Study groups in NCT05989802
Study groupRoleWhat they receive
Evaluation of various novel TB triage and diagnostic testsExperimentalThe 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion with positive index test result among participants with tuberculosis (TB)

    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)

    Measured: 2 years

  2. Proportion with negative index test result among participants without tuberculosis (TB)

    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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start26 Jan 2024
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05989802
Sponsor's protocol ID
R01HL169449
Other IDs
U01AI152087, 7200AA22RFA00004, R01HL169449
Status last verified
Oct 2026
First submitted
28 Jul 2023
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Perez-Velez CM, Marais BJ. Tuberculosis in children. N Engl J Med. 2012 Jul 26;367(4):348-61. doi: 10.1056/NEJMra1008049. No abstract available.

    PubMed 22830465

  • 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.

  • Graham SM, Cuevas LE, Jean-Philippe P, Browning R, Casenghi M, Detjen AK, Gnanashanmugam D, Hesseling AC, Kampmann B, Mandalakas A, Marais BJ, Schito M, Spiegel HM, Starke JR, Worrell C, Zar HJ. Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children: An Update. Clin Infect Dis. 2015 Oct 15;61Suppl 3(Suppl 3):S179-87. doi: 10.1093/cid/civ581.

    PubMed 26409281

  • 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.

  • Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH, O'Brien RJ, Pai M, Richeldi L, Salfinger M, Shinnick TM, Sterling TR, Warshauer DM, Woods GL. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. 2017 Jan 15;64(2):111-115. doi: 10.1093/cid/ciw778.

    PubMed 28052967

  • WHO consolidated guidelines on tuberculosis: Module 5: Management of tuberculosis in children and adolescents [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579387/

    PubMed 35404556

  • Jaganath D, Beaudry J, Salazar-Austin N. Tuberculosis in Children. Infect Dis Clin North Am. 2022 Mar;36(1):49-71. doi: 10.1016/j.idc.2021.11.008.

    PubMed 35168714

  • Zawedde-Muyanja S, Reuter A, Tovar MA, Hussain H, Loando Mboyo A, Detjen AK, Yuen CM. Provision of Decentralized TB Care Services: A Detect-Treat-Prevent Strategy for Children and Adolescents Affected by TB. Pathogens. 2021 Dec 1;10(12):1568. doi: 10.3390/pathogens10121568.

    PubMed 34959523

  • Dodd PJ, Yuen CM, Sismanidis C, Seddon JA, Jenkins HE. The global burden of tuberculosis mortality in children: a mathematical modelling study. Lancet Glob Health. 2017 Sep;5(9):e898-e906. doi: 10.1016/S2214-109X(17)30289-9.

    PubMed 28807188

  • 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.

  • Andama A, Whitman GR, Crowder R, Reza TF, Jaganath D, Mulondo J, Nalugwa TK, Semitala FC, Worodria W, Cook C, Wood RC, Weigel KM, Olson AM, Lohmiller Shaw J, Kato-Maeda M, Denkinger CM, Nahid P, Cangelosi GA, Cattamanchi A. Accuracy of Tongue Swab Testing Using Xpert MTB-RIF Ultra for Tuberculosis Diagnosis. J Clin Microbiol. 2022 Jul 20;60(7):e0042122. doi: 10.1128/jcm.00421-22. Epub 2022 Jun 27.

    PubMed 35758702

  • Nkereuwem E, Togun T, Gomez MP, Szekely R, Mace A, Jobe D, Schumacher SG, Kampmann B, Denkinger CM; Reach4KidsAfrica (R4KA) Consortium. Comparing accuracy of lipoarabinomannan urine tests for diagnosis of pulmonary tuberculosis in children from four African countries: a cross-sectional study. Lancet Infect Dis. 2021 Mar;21(3):376-384. doi: 10.1016/S1473-3099(20)30598-3. Epub 2020 Dec 11.

    PubMed 33316214

  • Yellapu GD, Rudraraju G, Sripada NR, Mamidgi B, Jalukuru C, Firmal P, Yechuri V, Varanasi S, Peddireddi VS, Bhimarasetty DM, Kanisetti S, Joshi N, Mohapatra P, Pamarthi K. Development and clinical validation of Swaasa AI platform for screening and prioritization of pulmonary TB. Sci Rep. 2023 Mar 23;13(1):4740. doi: 10.1038/s41598-023-31772-9.

    PubMed 36959347

Questions about this trial

What is this clinical trial studying?

A study testing Oral swab molecular testing, Automated Cough Sound Analysis and Automated Lung Sound Analysis in people with Tuberculosis and Diagnostics, run by University of California, San Francisco at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Mozambique, South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Devan Jaganath, MD (415-514-4692, devan.jaganath@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion with positive index test result among participants with tuberculosis (TB) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05989802, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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