Clinical Characteristics and Outcome of Patients With COP... | NCT04966026

Studies
Clinical Characteristics and Outcome of Patients With COPD With Pneumonia

NCT04966026

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 19, 2021Actual

Enrollment

143Actual

Phase

Not provided

Conditions

Pneumonia
Chronic Obstructive Pulmonary Disease

Interventions

No inervention

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

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

May 2018

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

Mar 1, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

May 30, 2018Actual

First Submitted Date

Jul 4, 2021

First Submission Date that Met QC Criteria

Jul 14, 2021

First Posted Date

Jul 19, 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 14, 2021

Last Update Posted Date

Jul 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Detailed Description

To identify the clinical characteristics of patients with chronic obstructive pulmonary disease (COPD) combined with community-acquired pneumonia (CAP) and the factors influencing clinical transition.Compared to other chronic airway diseases, COPD patients can often have CAP in combination, but there is a lack of comparative studies between COPD patients with CAP and non-COPD patients with CAP.

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

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD combined with CAP inpatients		(1) CAP meets the diagnostic criteria published in our 2016 CAP diagnosis and treatment guidelines; CPOPD and AECOPD meet the diagnostic criteria published in our 2013 COPD diagnosis and treatment guidelines; (2) age ≧ 18 years. Exclusion criteria: (1) age <18 years; (2) pregnancy; (3) positive human immunodeficiency virus (HIV) antibody; (4) suspected or confirmed tuberculosis or fungal infection of the lung.	Other: No inervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No inervention	Other	No inervention	COPD combined with CAP inpatients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rate	mortality rate	Day 28 from hospitalization

Secondary Outcomes

Measure	Description	Time Frame
Number of days in hospital	Number of days in hospital	through study completion, an average of 1 year
number of days in ICU	number of days in ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CAP meets the diagnostic criteria published in 2016 Chinese CAP diagnosis and treatment guidelines; CPOPD and AECOPD meet the diagnostic criteria published in Chinese 2013 COPD diagnosis and treatment guidelines;
Age ≧ 40years.

Exclusion Criteria:

age <40years;
pregnancy;
positive for human immunodeficiency virus (HIV) antibodies;
suspected or confirmed tuberculosis or fungal infection of the lung.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with COPD combined with pneumonia admitted to Peking University Third Hospital from March 1, 2017 to February 28, 2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yongchang Sun, MD	Peking University 3rd Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Beijing Municipality	100191	China

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia
D029424	Pulmonary Disease, Chronic Obstructive

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