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Clinical Trials in Japan / NCT07472114
Starting soon Not applicable

Effect of tNGS on CAP Patients With Initial Treatment Failure

NCT07472114 · tracked via the Priya Life Science Japan tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2026-04-10
Last updated
2026-03-16

Condition(s) studied

Community Acquired Pneumonia (CAP)

Investigational drug(s) / intervention(s)

Targeted next-generation sequencingConventional microbiological testingFollow-up at Day 30

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.

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults (age ≥ 18 years) * Diagnosed of community-acquired pneumonia * Initial treatment failure Exclusion Criteria: * tNGS or mNGS already performed on respiratory samples during the current illness * Suspected lung abscess or empyema * Cerebral infarction within the past three months * Dysphagia * Nasopharyngeal carcinoma currently receiving radiotherapy * Tracheostomy * Long-term bedridden patients (ADL score ≤ 60) * Pathogens identified within the past 7 days that adequately explain the current clinical presentation * Bronchiectasis with large amounts of sputum and documented bacterial detection within the past six months * Inability to obtain eligible respiratory samples * CURB-65 score ≤ 1 * Expected discharge or death within 48 hours

Primary outcome measure(s)

  • Length of hospital stay — 30 days
    Defined as the total number of hospital days by Day 30.

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07472114 on ClinicalTrials.gov ↗ ← All trials in Japan