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Sphingosine-1-phosphate and Pneumonia

NCT04007328 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-07-05

No results posted yet for this study

Summary

Pneumonia is a major infectious cause of death worldwide and imposes a considerable burden on healthcare resources. Sphingosine-1-phosphate (S1P) is a bioactive sphingolipid and 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 pulmonary leak and lung injury. Because of the involvement in lung injury, S1P could be the potential biomarker of pneumonia. Recently, our pilot study suggested that patients with CAP have significantly higher plasma S1P levels than healthy individuals. Interestingly, our observational study also showed significantly elevated S1P level in the patients who were treated with methylprednisolone during the hospitalization. Based on the above evidence, we hypothesize that S1P plays an important role in the pathobiology of pneumonia. Moreover, S1P is not only a useful biomarker for diagnosis of CAP, but also can be an indicator for using corticosteroids adjuvant therapy.

Conditions

  • Pneumonia, Bacterial

Interventions

DRUG

Methylprednisolone Sodium Succinate

methylprednisolone vial

DRUG

Placebo

Normal saline manufactured to mimic methylprednisolone vial

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Ching-Wang Hsu, MD · Wan Fang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2021-04-30
Completion
2025-11-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007328 on ClinicalTrials.gov