NCT03728816

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

August 24, 2018

Last Update Submit

November 1, 2018

Conditions

Keywords

Community Acquired PneumoniaEpidemiologyMulticenter study

Outcome Measures

Primary Outcomes (3)

  • Microbiological profile of lower respiratory tract specimens

    Record the microbiological profile of lower respiratory tract specimens, including sputum, nasopharyngeal swabs, tracheobronchial aspirates and BAL fluid.

    Day 0 of the study

  • Microbiological profile of urine specimens

    Record the microbiological profile of urine specimens, including all the bacteria explored,especially legionella or streptoccus pneumonia.

    Day 0 of the study

  • Microbiological profile of serum specimens

    Record the microbiological profile of serum specimens , including all the bacteria explored, especially legionella, mycoplasma, chlamydia.

    Day 0,14 days or 21 days of the study

Secondary Outcomes (7)

  • General conditions of the participants

    Day 0 of the study

  • Inflammatory Parameters

    Day 0, 3 days of the study, and until the end of the study(approximately 1 year).

  • Arterial Blood Gas analysis of the participants

    Day 0 of the study

  • Chest Image of the participants

    Day 0 of the study

  • Pneumonia Severity Index of the participants

    Day 0 of the study

  • +2 more secondary outcomes

Study Arms (1)

SCAP groups

all the SCAP patients who meet the inclusion criteria

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SCAP patients who meet the inclusion criteria in China

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Jieming QU, h.D.,M.D.

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieming QU, Ph.D., M.D.

CONTACT

Jing ZHANG, h.D.,M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Respiratory Physician

Study Record Dates

First Submitted

August 24, 2018

First Posted

November 2, 2018

Study Start

November 10, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

November 2, 2018

Record last verified: 2018-11

Locations