Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia

The incidence rate and mortality of lung infection are high worldwide. It is a common and frequently occurring disease which seriously threatens human health. Severe pneumonia accounts for 18-36% of all pneumonia. Severe pneumonia has caused serious economic and medical burden. Therefore, it is urgent to carry out the real-world cohort study of severe pneumonia. Big data and sample library will provide useful clinical guidance and scientific research reserves for clinicians. Through further research, we can improve the treatment success rate and reduce the mortality.

The purpose of this study is to provide reliable biological samples and related data information for the relevant basic and clinical trials in the field of severe pneumonia by carrying out the construction of special disease cohort database and biological sample holographic database, and to establish a long-term sharing platform for the transformation of research results into clinical practice, improve the prognosis of severe pneumonia,and provide the evidence for improving the diagnosis and treatment of severe pneumonia suitable for China's national conditions.

Study Overview

• Status: Recruiting
• Conditions: Severe Pneumonia; Special Disease Cohort Database; Holographic Library of Biological Samples

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jieming Qu, MD,PhD; Phone Number: +86-21-64370045; Email: jmqu0906@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Medical School of Shanghai Jiaotong University
      • Contact: Jieming Qu, MD, PhD; Phone Number: 86-21-64370045; Email: jmqu0906@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of severe pneumonia

Description

Inclusion Criteria:

• Recent cough, expectoration or aggravation of original respiratory diseases, with or without purulent sputum / chest pain / dyspnea / hemoptysis
• Fever
• Signs of pulmonary consolidation and / or moist rales
• Peripheral blood leukocytes >10×10^9/L or less than 4×10^9/L, with or without nucleus shifting to the left.
• New patchy infiltration, consolidation of lobes / segments, ground glass opacity or interstitial changes, with or without pleural effusion on chest imagings
• Positive etiological examination
• Age > 18 years old
• Need mechanical ventilation; septic shock need vasoactive drug treatment. Meet one of them.
• ① respiratory rate ≥ 30 beats / min; ② oxygenation index (PaO2 / FiO2) ≤ 250; ③ multilobar infiltration; ④ disturbance of consciousness / disorientation; ⑤ azotemia (BUN ≥ 20mg / dl); ⑥ cytopenia (WBC < 4.0 × 109 / L); ⑦ thrombocytopenia (platelet < 10.0 × 109 / L); Ⅷ low body temperature (T < 36 ℃); Ⅸ hypotension, requiring strong fluid resuscitation. Meet the above three requirements at the same time.

Exclusion Criteria:

● Cannot understand and / or implement the investigation protocol.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
severe pneumonia; Patients with severe pneumonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome of patients with severe pneumonia	The pneumonia is cured or improved, or the treatment of pneumonia is invalid, or the patient is dead.	day 3, day 7, day 14, day 30, day 180.

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Jieming Qu, MD,PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: SHDC2020CR010-001

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