Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia

August 6, 2024 updated by: Mei Kang, Shanghai General Hospital, China

Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia: a Longitudinal Observational Study

The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. The main questions it aims to answer is:

What is the pathogenic profile of SP patient admitted in intensive care unit (ICU) during and after COVID-19 pandemic? What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU? Are those indexes mentioned above associated with the prognosis of SP?

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This is a multi-center, longitudinal, observational study.

Participants

SP patients will be continuously recruited in ICU department in Shanghai General Hospital and respiratory-specific ICU (RICU) department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to December 31, 2024.

The investigators applied the AmericanThoracic Society(ATS)/Infectious Diseases Society of America (IDSA) major criteria to a cohort of patients hospitalized in two tertiary hospitals with severe pneumonia in order to describe its epidemiology, microbiology, and outcomes.

Assessment of disease progression

  1. Shock: Definition: A systemic pathological process in which the effective circulating blood volume is reduced due to various reasons and the tissue microcirculation perfusion is seriously insufficient, resulting in cell damage and serious dysfunction of function and metabolism of important organs. Overall arterial pressure decline: systolic blood pressure less than 90mmHg or mean arterial pressure (MAP) less than 70mmHg, accompanied by tachycardia. Clinical signs of hypoperfusion: skin damp cold with vasoconstriction and cyanosis; Kidney urine volume is less than 0.5ml/kg/h; The nervous system includes changes in mind (dullness of reaction, loss of orientation and confusion). Hyperlactacidemia: greater than 2mmol/L.
  2. Invasive mechanical ventilation: (1) Definition: Support of ventilation and improvement of oxygenation by inserting an intubation tube into the trachea and delivering warm, fully oxygenated, and moist gases to the airways and lungs at pressures above atmospheric pressure. (2) Classification: invasive ventilator-assisted ventilation under tracheal intubation, invasive ventilator-assisted ventilation under tracheal incision.
  3. High fever: body temperature (armpit temperature) exceeds 39 ° C. (Note: High fever is generally defined at 38.5℃ in clinical practice.)
  4. The above symptoms persist: shock for more than 3 days, high fever for more than 3 days, mechanical ventilation for more than 1 week.

Indicators

  1. Sociodemographic indexes: sex, age, personal history
  2. Clinical indicators: clinical diagnosis, past history, present history, treatment history, laboratory examination, clinical prognosis
  3. Laboratory examination : culture, species of infectious agent, antibiotic susceptibility test Microbiological etiological identification methods include: ① oral and pharyngeal swabs: polymerase chain reaction (PCR) for COVID-19 nucleic acid; ② Nasopharyngeal swab: PCR for influenza A virus nucleic acid; ③ Rectal swab: Macconkey plate + drug-sensitive paper was used to detect the presence of carbapenem-resistant gram-negative bacillus, and loop-mediated isothermal amplification was used to identify the presence of IPM, VIM, NDM, KPC, OXA and other resistance genes. ④ Smear: Various specimens are diluted and stained to observe whether there are bacteria and fungi and their morphology; ⑤ Culture: microbial culture of various specimens, and drug sensitivity test to determine drug resistance; ⑥ Quick test: Rapid detection of infectious diseases, including 17 bacteria and 7 fungi; ⑦ Immunofluorescence staining: Use fluorescein to label fungal cell wall, observe fungal morphology under fluorescence microscope for qualitative detection; ⑧ Next generation sequencing (NGS).

Other laboratory tests: Blood routine (white blood cell count, neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio (NLR), C-reactive protein (CRP), procalcitonin (PCT)).

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Mei Kang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Severe pneumonia patients admitted in ICU department in Shanghai General Hospital and respiratory-specific ICU department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to April 28, 2024.

Description

Inclusion Criteria:

  • At least 18 years of age
  • Clinical diagnosed of severe pneumonia (case definition: adults according to "Diagnosis and Treatment of Adults with Community-acquired Pneumonia"-- An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America, 2019)
  • Have at least one microbiological test result

Exclusion Criteria:

  • No data of clinical prognosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Severe pneumonia

Severe pneumonia patients will be continuously recruited in ICU department in Shanghai General Hospital (n=450) and RICU in the First Affiliated Hospital of Chongqing Medical University (n=150) during June 1, 2022 to April 28, 2024.

Severe pneumonia was defined as meeting either one major criteria (septic shock with need of vasopressors or respiratory failure requiring mechanical ventilation) or three minor (laboratory and physiologic markers such as uremia or hypothermia) criteria according to the ATS/IDSA major criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: up to 3 months
Number of Participants with fatal outcomes out of all participants
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay in ICU
Time Frame: through study completion, an average of 38 days
Number of days since admitted to ICU for each patient
through study completion, an average of 38 days
duration of mechanical ventilation
Time Frame: through study completion, an average of 25 days
Number of days of mechanical ventilation treatment for each patient
through study completion, an average of 25 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, China

Collaborators

First Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Mei Kang, MPH, Clinical Research Center, Shanghai General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets used in this study are available upon request to the principle investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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