NCT04959955

Brief Summary

  1. 1.Objective to understand the proportion of atypical pathogens in the pathogens of SCAP and AECOPD in urban hospitals in China.
  2. 2.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.
  3. 3.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.
  4. 4.Objective to evaluate the advantages of various diagnostic methods for atypical pathogens causing lower respiratory tract infection.
  5. 5.It is suggested that the current empirical treatment of SCAP and severe COPD in China should be improved.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

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

August 8, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2016

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

July 4, 2021

Last Update Submit

July 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of atypical pathogens and mixed infections

    Incidence of atypical pathogens and mixed infections

    2year Incidence

Study Arms (2)

AECOPD group

CAP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • SCAP
  • AECOPD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 13, 2021

Study Start

August 8, 2015

Primary Completion

July 10, 2016

Study Completion

December 12, 2019

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share