NCT07472114

Effect of tNGS on CAP Patients With Initial Treatment Failure

Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized controlled trial designed to evaluate the impact of tNGS in patients with community-acquired pneumonia who experience initial treatment failure.

Detailed description

Community-acquired pneumonia (CAP) is a common respiratory disease and poses a major threat to global health. CAP can be caused by a wide range of respiratory pathogens, including viruses, bacteria, and fungi. However, conventional microbiological tests often fail to identify the causative pathogens, making etiological diagnosis challenging and limiting the implementation of individualized treatment strategies, which may affect patient prognosis. Targeted next-generation sequencing (tNGS) enables the simultaneous detection of hundreds of common respiratory pathogens at a relatively low cost and has significantly improved pathogen detection rates. To further evaluate the impact of tNGS on clinical decision-making and patient outcomes in real-world practice, a multicenter randomized controlled trial is proposed by the investigators, enrolling patients with community-acquired pneumonia who experience initial treatment failure. Participants will be randomly assigned in a 1:1 ratio to either the tNGS group or the conventional testing group. Patients in the tNGS group will undergo tNGS in addition to conventional microbiological testing, whereas those in the conventional testing group will receive conventional microbiological testing alone. Length of hospital stay and other clinical effectiveness endpoints will be compared between the two groups.

Conditions

• Community Acquired Pneumonia (CAP)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Targeted next-generation sequencing	Bronchoalveolar lavage fluid (BALF) or sputum samples will be collected within 72 hours after randomization and sent for targeted next-generation sequencing (tNGS). The test results will be reported to the attending physician within 1-2 days.
DIAGNOSTIC_TEST	Conventional microbiological testing	Bronchoalveolar lavage fluid (BALF) or sputum samples will be collected within 72 hours after randomization and sent for conventional microbiological testing. The type of conventional microbiological testing will be determined by the attending physician, and test results will be reported in approximately one week
OTHER	Follow-up at Day 30	A telephone visit will be conducted on or around Day 30 for study participants who are discharged or transferred to another hospital due to disease exacerbation, to collect information on survival, ICU admissions, mechanical ventilation, and medical costs.

Timeline

• Start date: 2026-04-10
• Primary completion: 2027-12-31
• Completion: 2028-02-28
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China