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A Pragmatic Randomized Trial Comparing TBLAMP First and Smear First Diagnostic Pathways for Pulmonary Tuberculosis in a Community Hospital

A Pragmatic Randomized Trial Comparing TBLAMP First and Smear First Diagnostic Pathways for Pulmonary Tuberculosis in a Community Hospital

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260401012
Enrollment
200
Registered
2026-04-01
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Tuberculosis Tuberculosis Smear Negative Tuberculosis Tuberculosis Pulmonary Tuberculosis Molecular Diagnostic Techniques Loop Mediated Isothermal Amplification TB LAMP Sputum Smear Microscopy

Interventions

Participants randomized to this arm will undergo sputum smear microscopy as the initial diagnostic test. If smear is positive, tuberculosis treatment will proceed according to standard guidelines and
Smear First Diagnostic Pathway,TBLAMP First Diagnostic Pathway

Sponsors

Pluak Daeng Hospital Rayong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Presumptive pulmonary tuberculosis based on clinical symptoms and chest radiography 3. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Previous tuberculosis treatment within the past 12 months 2. Clinical condition requiring immediate tuberculosis treatment before diagnostic allocation 3. Unable to complete follow up for primary outcome

Design outcomes

Primary

MeasureTime frame
Time to treatment initiation Within 30 days after enrollment Calendar days from first sputum collection to initiation of tuberculosis treatment

Secondary

MeasureTime frame
Proportion initiating treatment within 48 hours 48 hours after enrollment Percentage of participants initiating treatment within 48 hours,Loss to follow up before treatment 30 days after enrollment Proportion of participants not initiating treatment within 30 days

Countries

Thailand

Contacts

Public ContactChinnawat Chainual

Pluakdaeng Hospital

khunmortu@hotmail.com033650413

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026