Evaluating new TB diagnostic tests for children

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

This study aims to assess novel, point-of-care diagnostic tests for tuberculosis (TB) in children under 15 years old. Given the challenges of obtaining sputum samples and the low bacillary burden in pediatric TB cases, the study will evaluate non-sputum biomarker-based tests that could facilitate faster diagnosis and treatment. The research will involve clinical assessments of the sensitivity and specificity of these tests, as well as their usability and acceptability among healthcare workers. The goal is to reduce the high mortality rate associated with childhood TB by providing simpler and more effective diagnostic tools.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Nacional de Saúde
  Maputo, Mozambique Recruiting
• Dora Nginza Hospital
  Cape Town, South Africa Not yet recruiting
• Mulago National Referral Hospital
  Kampala, Uganda Not yet recruiting

Study contacts

• Principal investigator: Adithya Cattamanchi, MD, MAS — University of California, Irvine
• Study coordinator: Devan Jaganath, MD
• Email: devan.jaganath@ucsf.edu
• Phone: 415-514-4692

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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.