NCT04966026

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

July 4, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    mortality rate

    Day 28 from hospitalization

Secondary Outcomes (5)

  • Number of days in hospital

    through study completion, an average of 1 year

  • number of days in ICU

    through study completion, an average of 1 year

  • number of days on mechanical ventilation

    through study completion, an average of 1 year

  • cause of using antimicrobial drugs

    through study completion, an average of 1 year

  • hospital fees

    through study completion, an average of 1 year

Study Arms (1)

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

No inervention

COPD combined with CAP inpatients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

PneumoniaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yongchang Sun, MD

    Peking University 3rd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 19, 2021

Study Start

March 1, 2017

Primary Completion

February 28, 2018

Study Completion

May 30, 2018

Last Updated

July 19, 2021

Record last verified: 2018-05

Locations