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

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

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation; CAP
• Intervention / Treatment: Diagnostic test

• Study Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AECOPD group
CAP group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2015
• Primary Completion (Actual): July 10, 2016
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: LM2016057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No