Comparison of sputum induction and bronchoscopy in diagnosis of pulmonary tuberculosis: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260223007

Enrollment

276

Registered

2026-02-23

Start date

2024-11-01

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 Pulmonary Tuberculosis Bronchoscopy Bronchoalveolar Lavage Sputum Induction Diagnostic Techniques Respiratory System Polymerase Chain Reaction Mycobacterial Culture Randomized Controlled Trial

Interventions

Sputum induction was performed using nebulized hypertonic saline to obtain respiratory specimens for acid-fast bacilli smear, TB-PCR, and mycobacterial culture.,Flexible bronchoscopy with bronchoalveo

Experimental Procedure/Surgery,Active Comparator Procedure/Surgery

Induced sputum,Bronchoscopy with bronchoalveolar lavage

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Suspected pulmonary tuberculosis 3. Inability to expectorate sputum spontaneously OR negative initial spontaneous sputum acid-fast bacilli smear 4. Radiographic findings suggestive of pulmonary tuberculosis 5. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability 2. Severe hypoxemia defined as oxygen saturation less than 92 percent on room air 3. Pregnancy 4. Contraindications to bronchoscopy

Design outcomes

Primary

Measure	Time frame
Final diagnosis of pulmonary tuberculosis At completion of diagnostic evaluation (index admission) Proportion of participants diagnosed with pulmonary tuberculosis in each randomized arm (microbiologically confirmed or clinically established diagnosis)	—

Secondary

Measure	Time frame
Microbiological confirmation rate At completion of diagnostic testing Proportion of participants with microbiologically confirmed pulmonary tuberculosis based on AFB smear, TB-PCR, or mycobacterial culture,Additional diagnostic yield after negative initial test During diagnostic workup Number and proportion of additional tuberculosis diagnoses obtained following negative initial assigned diagnostic procedure	—

Measure

Time frame

Microbiological confirmation rate At completion of diagnostic testing Proportion of participants with microbiologically confirmed pulmonary tuberculosis based on AFB smear, TB-PCR, or mycobacterial culture,Additional diagnostic yield after negative initial test During diagnostic workup Number and proportion of additional tuberculosis diagnoses obtained following negative initial assigned diagnostic procedure

—

Countries

Thailand

Contacts

Public ContactPhanchanit Arayatrakullikhit

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Phanchanit.mim@gmail.com0895642592

Outcome results

None listed

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