Project to Improve the Diagnosis and Treatment Ability of... | NCT04959955

Studies
Project to Improve the Diagnosis and Treatment Ability of Adult Severe Community Acquired Lower Respiratory Tract Infection

NCT04959955

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 13, 2021Actual

Enrollment

200Actual

Phase

Not provided

Conditions

CAP
COPD Exacerbation

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2015Actual

Primary Completion Date

Jul 10, 2016Actual

Completion Date

Dec 12, 2019Actual

First Submitted Date

Jul 4, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 13, 2021Actual

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 4, 2021

Last Update Posted Date

Jul 13, 2021Actual

Name	Class
First Hospital of China Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Objective to understand the proportion of atypical pathogens in the pathogens of SCAP and AECOPD in urban hospitals in China.
Objective to investigate the antimicrobial resistance of atypical pathogens in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and SCAP in urban hospitals.
Objective to master the important clinical characteristics of patients with acute exacerbation of SCAP and COPD caused by atypical pathogens and mixed infection in urban hospitals in China, and to put forward the experience judgment index.
Objective to evaluate the advantages of various diagnostic methods for atypical pathogens causing lower respiratory tract infection.
It is suggested that the current empirical treatment of SCAP and severe COPD in China should be improved.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

200Actual

Name	Type	Description	Arm Group Labels	Other Names
	Diagnostic Test		AECOPD group CAP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of atypical pathogens and mixed infections	Incidence of atypical pathogens and mixed infections	2year Incidence

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SCAP
AECOPD

Exclusion Criteria:

Pregnant or lactating women.
- Patients with bronchiectasis.
  - Patients with active pulmonary tuberculosis.
    - Aspiration pneumonia or obstructive pneumonia.
      - Two weeks before the onset of hospital treatment history, this infection can not be excluded from hospital acquired infection.
        
        HIV positive patients (but HIV testing is not required).
        
        Patients who are unable and / or unable to understand and / or implement the investigation protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult hospitalized cases of SCAP and acute exacerbation of COPD were collected from 12 medical institutions in 10 cities in China within 2 years.

Sampling Method

Non-Probability Sample

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