NCT04433403

Brief Summary

This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

June 13, 2020

Last Update Submit

September 20, 2021

Conditions

Pathogenic Microorganism of Serious Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province

    Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing

    2020.7-2023.12

Interventions

pathogenic microorganismOTHER

Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Severe pneumonia patients, aged 18 years and above, gender unlimited.

You may qualify if:

  • Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy.
  • Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 \< 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC \< 4 × 109 / L); thrombocytopenia (\< 10 × 109 / L); hypothermia (T \< 36 ℃).

You may not qualify if:

  • refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy director of emergency department

Study Record Dates

First Submitted

June 13, 2020

First Posted

June 16, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

September 22, 2021

Record last verified: 2021-09

Locations

CN(1)