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

Severe Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882436
• Other study ID #: SHDC2020CR010-001
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2021
• Source: Ruijin Hospital
• Contact: Jieming Qu, MD,PhD
• Phone: +86-21-64370045
• Email: jmqu0906[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

• ? respiratory rate = 30 beats / min; ? oxygenation index (PaO2 / FiO2) = 250; ? multilobar infiltration; ? disturbance of consciousness / disorientation; ? azotemia (BUN = 20mg / dl); ? cytopenia (WBC < 4.0 × 109 / L); ? thrombocytopenia (platelet < 10.0 × 109 / L); ? low body temperature (T < 36 ?); ? hypotension, requiring strong fluid resuscitation. Meet the above three requirements at the same time.

Exclusion Criteria:

? Cannot understand and / or implement the investigation protocol.

Related Conditions & MeSH terms

• Pneumonia
• Severe Pneumonia

Locations

Country	Name	City	State
China	Ruijin Hospital, Medical School of Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.