The Association Mechanism Between the Microbiome and the... | NCT06896019 | Trialant

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The Association Mechanism Between the Microbiome and the... | NCT06896019 | Trialant

Studies
The Association Mechanism Between the Microbiome and the Development of Community Pneumonia Was Studied Based on the Analysis of Pulmonary Microbiota - Host Interaction Network

NCT06896019

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

Active, not recruiting

Last Update Posted

Mar 26, 2025Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Community Pneumonia

Interventions

Community Pneumonia

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT06896019

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

SYSKY-2024-628-01

Secondary IDs

Not provided

Brief Title

The Association Mechanism Between the Microbiome and the Development of Community Pneumonia Was Studied Based on the Analysis of Pulmonary Microbiota - Host Interaction Network

Official Title

The Association Mechanism Between the Microbiome and the Development of Community Pneumonia Was Studied Based on the Analysis of Pulmonary Microbiota - Host Interaction Network

Acronym

Not provided

Organization

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jun 1, 2023Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Dec 12, 2025Estimated

First Submitted Date

Mar 20, 2025

First Submission Date that Met QC Criteria

Mar 20, 2025

First Posted Date

Mar 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2025

Last Update Posted Date

Mar 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

No

Is FDA Regulated Device

No

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The difference of lung flora between the healthy group and the CAP group was compared, and the core flora involved in the development of CAP was identified.
To predict the metabolites associated with CAP.
Identification of genes related to immune response in CAP.
Construct the pulmonary microbiota - host interaction network with metabolites as the link.

Detailed Description

Not provided

Conditions Module

Conditions

Community Pneumonia

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

No

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAP			Diagnostic Test: Community Pneumonia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Community Pneumonia	Diagnostic Test	The BALF of CAP patients	CAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Community Pneumonia	mNGS	1 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

According to the CAP clinical diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults in China (2016 edition), cases eligible for community-acquired pneumonia were included and screened.

Exclusion Criteria:

Alveolar lavage fluid samples without electronic bronchoscopy were excluded for mNGS etiological examination of the case.

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients diagnosed with community-acquired pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sent Memorial Hospital		Guangzhou	Guangdong		China

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Plan to Share IPD

No

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Case-Only

Time Perspective

Retrospective

Masking Info

No data available

No data is available for this block.