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NCT05136560
Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Phase 1, PHASE2 trial testing Dexamethasone in Sepsis in 102 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | CHA University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 15 January 2021 |
| Primary completion | 30 December 2025 |
| Estimated completion | 28 February 2026 |
| Sites | 2 locations across South Korea |
Drugs / interventions tested
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT05136560
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Sepsis
Currently open trials in the same condition.
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- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
Other CHA University trials
Trials by the same sponsor.
- NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy · Phase 2 · not yet recruiting
- NCT07143812 — A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma · Phase 1 · recruiting
- NCT07151118 — ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer · recruiting
- NCT07142226 — Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC · recruiting
- NCT07027891 — The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05136560 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CHA University
- Last refreshed: 31 May 2025
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