NCT06065618

Brief Summary

At present, the epidemiological characteristics and the distribution of pathogens of community-acquired pneumonia in Shandong Province are not clear. In order to understand the characteristics of community-acquired pneumonia, the distribution of pathogens and the risk factors of complications in Shandong Province, it is necessary to carry out investigation and study, which will provide the basis and support for the future prospective cohort study of pulmonary infection.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

September 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 22, 2023

Last Update Submit

October 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The prevalence of CAP

    The prevalence of CAP

    Up to 12 months

Secondary Outcomes (2)

  • Severity Assessment: Curb-65

    Up to 12 months

  • Sputum culture

    Up to 12 months

Interventions

Without intervention

Eligibility Criteria

Age14 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients aged over 14 years with community-acquired pneumonia were confirmed by imaging.

You may qualify if:

  • Age \> 14 years.
  • In the community.
  • Chest X-ray showed patchy, patchy infiltrative shadows or interstitial changes with or without pleural effusion (in or out of hospital) .
  • Pneumonia-related clinical manifestations: 1) recent cough, expectoration or respiratory disease symptoms aggravated, and the emergence of purulent sputum, with or without chest pain. 2) fever: armpit temperature ≥37.3℃ or hypothermia: armpit temperature \<36℃. 3) signs of pulmonary consolidation and/or Wet Rales. 4) white blood cell \> 10 × 10\^9/L or \< 4 × 10\^9/L with or without left shift of nucleus. Comply with 1,2,3 above plus any one of 4 above.

You may not qualify if:

  • The patients were initially diagnosed with pulmonary neoplasms, tuberculosis, non-infectious interstitial disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil granulocyte infiltration and pulmonary vasculitis.
  • Human Immunodeficiency Virus.
  • The patient was readmitted within 72 hours of discharge and was classified as a single hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Methods

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 4, 2023

Study Start

September 22, 2023

Primary Completion

September 22, 2024

Study Completion

September 22, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations