Evaluation of Plasma Sphingosine-1-Phosphate as A Diagnostic and Prognostic Biomarkers of Community-Acquired Pneumonia

NCT03473119 | Unknown

• 1 other identifier: N201602089
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia is a major infectious cause of death worldwide and imposes a considerable burden on healthcare resources. Obstructive lung diseases (COPD and Asthma) are increasingly important causes of morbidity and mortality worldwide. The patients with community-acquired pneumonia (CAP), and acute exacerbations of obstructive lung diseases commonly present with similar signs and symptoms. For antibiotic use, the rapid and accurate differentiation of clinically relevant of bacterial lower respiratory tract infections from other mimics is essential. Sphingosine-1-phosphate (S1P) is a bioactive sphingolipid has both extracellular and intracellular effects in mammalian cells. S1P is involved in many physiological processes including immune responses and endothelial barrier integrity. In term of endothelial barrier integrity, S1P plays a crucial role in protecting lungs from the pulmonary leak and lung injury. Because of the involvement in lung injury, S1P would be the potential biomarker of pneumonia. Based on the above evidence, S1P plays an essential role in the pathobiology of pneumonia was hypothesized.

Conditions

Pneumonia; Chronic Obstructive Pulmonary Disease; Asthma

Keywords

Sphingosine-1-phosphate

Outcome Measures

Primary Outcomes (1)

• Mortality

  3 months mortality

  3 months

Secondary Outcomes (4)

• ICU

  During the hospital admission

• ETT

  During the hospital admission

• BiPAP

  During the hospital admission

• Length of Stay

  During the hospital admission

Study Arms (6)

Control

Healthy individuals

Asthma

Asthma acute exacerbations

Asthma with CAP

Asthma acute exacerbations with community-acquired pneumonia

COPD

Acute exacerbations of chronic obstructive pulmonary disease

COPD with CAP

Acute exacerbations of chronic obstructive pulmonary disease with community-acquired pneumonia

CAP

Community-acquired pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The individuals who have the target diseases (CAP, Asthma, Asthma with CAP COPD, and COPD with CAP) and healthy controls will be recruited at the emergency department (ED) of Wan Fang Hospital (Taipei, Taiwan). The hospital is affiliated with Taipei Medical University and is located in the metropolitan area of Taipei City, Taiwan, at Wenshan District, and has had more than 65,000 emergency visits annually.

You may qualify if:

• Clinical diagnosis of chronic obstructive pulmonary disease (COPD; ICD-9 codes 490-492, 494, 496)
• Clinical diagnosis of Asthma (ICD-9 code 493),
• Clinical diagnosis of pneumonia (ICD-9 codes 480-488).

You may not qualify if:

• Underage incapacity
• Pregnant women,
• Psychiatric history
• Unfamiliar with Chinese

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

The Emergency Department of Wan Fang Hospital

Taipei, Wenshan District, Taiwan

RECRUITING

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and Urine

MeSH Terms

Conditions

Pneumonia; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Shih-Chang Hsu, MD

CONTACT

29307930; 1980bradhsu@gmail.com

Chin-Wang Hsu, MD

CONTACT

Wan11119@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 22, 2018
• Study Start: March 19, 2016
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: July 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)