NCT07472114

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Feb 2028

First Submitted

Initial submission to the registry

March 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 10, 2026

Last Update Submit

March 12, 2026

Conditions

Community Acquired Pneumonia (CAP)

Keywords

targeted next generation sequencingcommunity acquired pneumoniaRCTinitial treatment failure

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Defined as the total number of hospital days by Day 30.

    30 days

Secondary Outcomes (10)

  • 30-day mortality

    30 days

  • ICU admission rate

    30 days

  • Length of stay in ICU

    30 days

  • Incidence of mechanical ventilation

    30 days

  • Duration of mechanical ventilation

    30 days

  • +5 more secondary outcomes

Other Outcomes (1)

  • Pathogen detection rate

    30 days

Study Arms (2)

tNGS group

EXPERIMENTAL

Lower respiratory tract samples collected (BALF, sputum); undergo targeted next-generation sequencing in addition to conventional microbiological testing; follow-up by telephone on day 30 (D30).

Diagnostic Test: Targeted next-generation sequencingDiagnostic Test: Conventional microbiological testingOther: Follow-up at Day 30

Control group

ACTIVE COMPARATOR

Lower respiratory tract samples collected (BALF, sputum); undergo conventional microbiological testing; follow-up by telephone on day 30 (D30).

Diagnostic Test: Conventional microbiological testingOther: Follow-up at Day 30

Interventions

Targeted next-generation sequencingDIAGNOSTIC_TEST

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.

Also known as: tNGS test
tNGS group
Conventional microbiological testingDIAGNOSTIC_TEST

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

Control grouptNGS group
Follow-up at Day 30OTHER

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.

Control grouptNGS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (age ≥ 18 years)
  • Diagnosed of community-acquired pneumonia
  • Initial treatment failure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Binghuai Lu, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

  • Bin Cao, M.D.

    China-Japan Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Yeming Wang, M.D.

CONTACT

+86 84206264wwyymm_love@163.com

Mengwei Yan

CONTACT

yanmengwei_happy@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 16, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

IPD used in the results publication will be shared.

Shared Documents
ICF, CSR

Locations

CN(1)