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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

Tracking Information
First Submitted Date August 24, 2018
First Posted Date November 2, 2018
Last Update Posted Date November 2, 2018
Estimated Study Start Date November 10, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 1, 2018)
  • 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.
  • 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.
  • 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.
  • Chest Image of the participants [ Time Frame: Day 0 of the study ]
    Record the chest radiograph of the participants when included in the study.
  • 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.
  • 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%.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
Official Title Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population SCAP patients who meet the inclusion criteria in China
Condition Community-acquired Pneumonia
Intervention Not Provided
Study Groups/Cohorts SCAP groups
all the SCAP patients who meet the inclusion criteria
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 1, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728816
Other Study ID Numbers RJ2017NO186-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jieming QU, Ruijin Hospital
Study Sponsor Ruijin Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jieming QU, h.D.,M.D. Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date November 2018