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Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

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ClinicalTrials.gov Identifier: NCT03728816
Recruitment Status : Unknown
Verified November 2018 by Jieming QU, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jieming QU, Ruijin Hospital

Brief Summary:
This study is aimed to understand the clinical characteristics, etiology and resistance phenotype of major pathogens of SCAP in China through multicenter and prospective investigation. Thus to provide epidemiological basis for improving the SCAP diagnosis and treatment protocol suitable for China.

Condition or disease
Community-acquired Pneumonia

Detailed Description:

During the study period, all patients who are diagnosed with SCAP and meet the inclusion criteria in the participating unit should be enrolled in the study . At the end of the trial, each participating unit should complete at least 20 qualified cases, and all participating units should have a total of more than 300 qualified cases.

  1. Learn about the etiology of SCAP in China.
  2. Grasp the resistance phenotype and molecular epidemiology of major pathogens of SCAP in China.
  3. Know the important clinical characteristics of SCAP in China, including age, basic diseases, length of hospital stay, length of stay in ICU, duration of mechanical ventilation, clinical manifestations, imaging findings, complications, mortality, etc.
  4. Analyze and clarify the clinical risk factors of affecting SCAP mortality.
  5. Understand the current situation of antibiotic treatment of SCAP in China.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
Estimated Study Start Date : November 10, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
SCAP groups
all the SCAP patients who meet the inclusion criteria



Primary Outcome Measures :
  1. Microbiological profile of lower respiratory tract specimens [ Time Frame: Day 0 of the study ]
    Record the microbiological profile of lower respiratory tract specimens, including sputum, nasopharyngeal swabs, tracheobronchial aspirates and BAL fluid.

  2. Microbiological profile of urine specimens [ Time Frame: Day 0 of the study ]
    Record the microbiological profile of urine specimens, including all the bacteria explored,especially legionella or streptoccus pneumonia.

  3. Microbiological profile of serum specimens [ Time Frame: Day 0,14 days or 21 days of the study ]
    Record the microbiological profile of serum specimens , including all the bacteria explored, especially legionella, mycoplasma, chlamydia.


Secondary Outcome Measures :
  1. General conditions of the participants [ Time Frame: Day 0 of the study ]
    Record the general conditions of the participants when included in the study ,such as demographic , clinical symptoms and signs of the participants, legionella contact history , enrollment date, ICU admitted condition, comorbidities, prior antibiotic treatment and so on.

  2. Inflammatory Parameters [ Time Frame: Day 0, 3 days of the study, and until the end of the study(approximately 1 year). ]
    Record the levels of WBC, CRP, PCT of the participants.

  3. Arterial Blood Gas analysis of the participants [ Time Frame: Day 0 of the study ]
    Record the arterial Blood Gas analysis(pH,PO2,PCO2 etc.) when included in the study.

  4. Chest Image of the participants [ Time Frame: Day 0 of the study ]
    Record the chest radiograph of the participants when included in the study.

  5. Pneumonia Severity Index of the participants [ Time Frame: Day 0 of the study ]
    Record the pneumonia severity index of the participants according to the PSI scoring system,which has been used to decide whether patients with pneumonia can be treated as outpatients or as (hospitalized) inpatients.

  6. CURB-65 Score of the participants [ Time Frame: Day 0 of the study ]
    Assessment of consciousness, urea, respiratory rate, BP, and age 65 years score of the participants(Confusion-1,BUN>7mmol/l-1,Respiratory rate≥30-1,SBP<90mmHg,DBP≤60mmHg-1,Age≥65-1).The risk of death at 30 days increases as the score increases:0-0.6%,1-2.7%,2-6.8%,3-14.0%,4-27.8%,5-27.8%.

  7. Prognosis of the SCAP participants [ Time Frame: up to 3 days of the study and until the end of the study(approximately 1 year). ]
    Record the prognosis(cure,improvement,invalid,recrudesce,death) of the participants through the study completion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SCAP patients who meet the inclusion criteria in China
Criteria

Inclusion Criteria:

  • Age >18 yeas;
  • Diagnosis of CAP according to the diagnosis and treatment of community-acquired pneumonia in adults: 2016 clinical practice guidelines by the Chinese Thoracic Society, Chinese Medical Association.

Exclusion Criteria:

  • Bronchiectasis;
  • Active tuberculosis;
  • Aspiration pneumonia or obstructive pneumonia;
  • Hospitalized in 2 weeks;
  • Hospitalized or ventilated ≥5 days;
  • Severe immunosuppression patients;
  • Irregular follow-up and lost follow-up;
  • Withdraw from the study for any reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728816


Contacts
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Contact: Jieming QU, Ph.D., M.D. 0086-021-64370045 jmqu0906@163.com
Contact: Jing ZHANG, h.D.,M.D. 0086-13472782754 jingatlas@hotmail.com

Locations
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China, Shanghai
Ruijin Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Jieming QU, Ph.D., M.D.    0086-021-64370045    jmqu0906@163.com   
Principal Investigator: Jieming QU, Ph.D., M.D.         
Principal Investigator: Jing ZHANG, Ph.D., M.D.         
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Jieming QU, h.D.,M.D. Ruijin Hospital
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Responsible Party: Jieming QU, Associate Chief Respiratory Physician, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03728816    
Other Study ID Numbers: RJ2017NO186-1
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jieming QU, Ruijin Hospital:
Community Acquired Pneumonia
Epidemiology
Multicenter study
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections