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
- Tuberculosis
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Universitas Padjadjaran
- Enrolment target
- 40,000
- Started
- 1 April 2026
- Main results due
- 31 March 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 29 days and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Bandung District Health Office
Bandung, West Java, Indonesia
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07293455. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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