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RECRUITINGINTERVENTIONAL

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

Rapid Research in Diagnostics Development for Tuberculosis Network (R2D2 Kids) and Assessing Diagnostics At Point-of-care for Tuberculosis in Children (ADAPT for Kids)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 willing to sign a consent form will be excluded. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (3)

Instituto Nacional de Saúde
Maputo, Mozambique
Dora Nginza Hospital
Cape Town, South Africa
Mulago National Referral Hospital
Kampala, Uganda