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NCT05136560

Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

Recruiting now Phase 1, PHASE2 Last updated 31 May 2025
What this trial tests

Phase 1, PHASE2 trial testing Dexamethasone in Sepsis in 102 participants. Currently enrolling.

Timeline
15 January 2021
Primary endpoint
30 December 2025
28 February 2026

Quick facts

Lead sponsorCHA University
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment102
Start date15 January 2021
Primary completion30 December 2025
Estimated completion28 February 2026
Sites2 locations across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

CHA University

Who can join

19 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate the safety and efficacy of early administration of two different doses of dexamethasone in high risk septic patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dysregulated dendritic cells in sepsis: functional impairment and regulated cell death.
    Zheng LY, Duan Y, He PY, Wu MY, et al · · 2024 · cited 23× · PMID 38816685 · DOI 10.1186/s11658-024-00602-9
  2. Corticosteroids for treating sepsis in children and adults.
    Annane D, Briegel J, Granton D, Bellissant E, et al · · 2025 · cited 7× · PMID 40470636 · DOI 10.1002/14651858.cd002243.pub5
  3. Effects of Glucocorticoid Therapy on Sepsis Depend Both on the Dose of Steroids and on the Severity and Phase of the Animal Sepsis Model.
    Park YJ, Lee MJ, Bae J, Lee JH, et al · · 2022 · cited 7× · PMID 35330172 · DOI 10.3390/life12030421
  4. The DEXA-SEPSIS study protocol: a phase II randomized double-blinded controlled trial of the effect of early dexamethasone in high-risk sepsis patients.
    Choi K, Park JE, Kim A, Hwang S, et al · · 2022 · cited 6× · PMID 36116775 · DOI 10.15441/ceem.22.276

Verify or expand the search:

Other trials of Dexamethasone

Trials testing the same drug.

Other recruiting trials for Sepsis

Currently open trials in the same condition.

Other CHA University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05136560.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing