NCT07293455Recruiting
Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can increase TB notifications. The main questions it aims to answer are: (1) Does the diagnostic intervention package raise TB notifications by HCF?; (2) Does the diagnostic intervention package raise the proportion of patients with TB who are diagnosed with microbiological tests, lower the time needed for TB diagnosis, lower the number of visits to HCF before TB diagnosis, raise the use of TB tests by healthcare providers, and lower the costs for TB diagnosis? Researchers will compare the diagnostic intervention package provided to HCFs and the community in the intervention arm with the standard of care in the control arm to assess the intervention's effect. Healthcare providers will be trained to provide diagnostic interventions to patients visiting their HCFs and to community residents in the areas surrounding HCFs.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40000 (estimated)
- First submitted
- 5 Dec 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Universitas Padjadjaran
- Diseases
- Tuberculosis
- NCT number
- NCT07293455
What you commit to
- Study type: Interventional
- Planned participants: 40000
- From 1 Apr 2026 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have started TB treatment or TB prophylaxis therapy.
Who the study is looking for
- 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.
- 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
Age in the registry: 29 days to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bandung District Health Office Coordinator of this site? Confirm its status | Bandung | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.