Rapid Diagnosis of Severe Respiratory Tract Infectious Di... | NCT06533514

Studies
Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis

NCT06533514

Sponsor

Chinese PLA General Hospital

Status

Not yet recruiting

Last Update Posted

Aug 1, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Severe Pneumonia
Biomarkers

Interventions

Not provided

Countries

Not provided

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

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

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Estimated

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jul 23, 2024

First Submission Date that Met QC Criteria

Jul 30, 2024

First Posted Date

Aug 1, 2024Actual

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

Jul 30, 2024

Last Update Posted Date

Aug 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.

Detailed Description

Methods: The relationship between relevant biomarkers and stratified diagnosis was analyzed by collecting laboratory and etiological examinations of patients with severe pneumonia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mild		According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe.
moderate		According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe.
severe		According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The relationship between the patient's specific biomarker levels and clinical outcomes.	Treatment failure rate, Mortality rates, SOFA rating scale	1 mounth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets the diagnostic criteria for severe pneumonia；
Age≥18 years old and < 80 years old；
Willing to sign informed consent for the course of the study；

Exclusion Criteria:

Patients with intracranial hypertension, acute coronary syndrome, pleural fistula, pneumothorax, or subcutaneous emphysema;
Pregnant and lactating patients;
Severely hemodynamically unstable (an increase in vasopressors by more than 30% in the first 6 hours, or norepinephrine >0.5mg/kg/min);
Those who do not consent to participate in this study；

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Meets the diagnostic criteria for severe pneumonia；

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
fei xie, doctor	Contact	13911385976		xiefei0522@163.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided