New TB Diagnostics for Indonesia: Non-sputum Tests at Health Facilities
Official title: Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified
Run by Universitas Padjadjaran · NCT07293455 · Data updated 2026-11-12
This trial tests a package of near point-of-care TB tests and related care changes to see if TB notifications rise in Indonesian health facilities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 29 Days and up |
| Sex | All |
| Enrollment | 40000 (estimated) |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07293455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants include children aged 29 days to 14 years with prolonged cough or weight-related concerns and adults 15 years or older with TB-like symptoms.
✕Probably not a fit
Patients without TB or those already on TB treatment may not benefit from the new diagnostic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This cluster-randomized trial compares an intervention package that includes non-sputum-based TB tests (like tongue swabs) and supportive components against standard care in Indonesian health facilities and communities. It aims to measure changes in TB notifications, proportion of microbiologically confirmed diagnoses, diagnostic turnaround time, patient visits before diagnosis, clinician test use, and diagnostic costs. The study uses a multi-component approach with clinical algorithms, training, a promotional package for clinics and pharmacies, and household contact investigation. Outcomes will inform whether implementing these non-sputum-based diagnostics can improve TB detection and streamline care in resource-limited settings.
Why it matters
Potential benefit: If successful, patients could experience faster, more accurate TB diagnosis with fewer clinic visits and lower diagnostic costs.
How similar studies have gone: Previous validation and feasibility work in the EVIDENT program support the potential value of non-sputum-based diagnostics, with limited large-scale CRCT data in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between \>28 days and 14 years old with the following symptoms: * Cough ≥2 weeks * Acute malnutrition * Weight loss or weight faltering during the past 3 months among those who had contact history with patients with TB in the past 12 months. 2. Aged ≥15 years old who had a cough for ≥2 weeks or bloody cough, with or without the following symptoms: * Cough with/without sputum * Fever * Weight loss * Night sweat * Fatigue * Chest pain/discomfort * Breathlessness * Loss of appetite * Shivering Exclusion Criteria: * Have started TB treatment or TB prophylaxis therapy.
Where it's running
-
Bandung District Health Office
Bandung, West Java, Indonesia Recruiting
Study contacts
- Principal investigator: Bachti Alisjahbana, Professor, MD, PhD — Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran (RC3ID Unpad)
- Study coordinator: EVIDENT Study Contact Centre
- Email: evident.pokja3@gmail.com
- Phone: +6281324285417
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.