NCT06624436 (DEDICATE-LPS) is a Phase 4 clinical trial of Dexamethasone in Sepsis, sponsored by Radboud University Medical Center.

Who is sponsoring NCT06624436?

NCT06624436 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT06624436?

Interventions in NCT06624436: Dexamethasone, Tocilizumab, Anakinra, Placebo, LPS.

What condition does NCT06624436 study?

NCT06624436 studies Sepsis, Neuroinflammatory Response, Immunosuppresion, Endotoxemia, Anakinra, Dexamethasone, Tocilizumab.

Is NCT06624436 still recruiting?

NCT06624436 is currently recruiting now. Last updated 1 April 2025.

Last reviewed 2025-04-01 · How we verify

NCT06624436: DEDICATE-LPS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia

Recruiting now Phase 4 Last updated 1 April 2025

What this trial tests

Phase 4 trial testing Dexamethasone in Sepsis in 52 participants. Currently enrolling.

Timeline

24 October 2024

Primary endpoint
1 September 2025

1 December 2025

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	52
Start date	24 October 2024
Primary completion	1 September 2025
Estimated completion	1 December 2025
Sites	1 location across Netherlands

Drugs / interventions tested

Dexamethasone (dexamethasone) — full drug profile →
Tocilizumab (tocilizumab) — full drug profile →
Anakinra (ANAKINRA) — full drug profile →
Placebo
LPS — full drug profile →

Conditions studied

Sepsis — all drugs for Sepsis →
Neuroinflammatory Response — all drugs for Neuroinflammatory Response →
Immunosuppresion — all drugs for Immunosuppresion →
Endotoxemia — all drugs for Endotoxemia →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 35, male only, with Sepsis or Neuroinflammatory Response. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Between-group differences in plasma TNF concentrations upon the second LPS challenge
Time frame: 1 day (during second LPS challenge)
The effects of dexamethasone, tocilizumab and anakinra on the development of immunoparalysis in a repeated endotoxemia model in humans, reflected by between-group differences in plasma TNF concentrations upon the second LPS challenge.
Within and between-group differences in CSF TNF concentrations during repeated experimental human endotoxemia
Time frame: 8 days
The extent of the neuroinflammatory response as well as the effects of dexamethasone, tocilizumab and anakinra on neuroinflammation, reflected by within and between-group differences in CSF TNF concentrations during repeated experimental human endotoxemia

Sponsor's own description

The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are: * What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model? * What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model? Researchers will compare these drugs to a placebo (a look-alike substance that contains no drug). Participants will visit the Intensive Care research department on two or five occasions (screening included): * The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord. * The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group. During an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Trained Immunity: RoadMap for drug discovery and development.
van Puffelen JH, Campbell C, Gander-Meisterernst I, Holldack J, et al · · 2025 · PMID 41432375 · DOI 10.7554/elife.108465

Verify or expand the search:

Other trials of Dexamethasone

Trials testing the same drug.

NCT07543458 — Therapeutics for Moderate and Severe Dengue · Phase 3 · not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Sepsis

Currently open trials in the same condition.

NCT07507877 — Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness · recruiting
NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
NCT07154615 — Assessing Immune Dysfunction in Sepsis · 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 Radboud University Medical Center trials

Trials by the same sponsor.

NCT07485569 — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial · Phase 1 · not yet recruiting
NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07514325 — MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer · NA · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06624436 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 1 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 Radboud University Medical Center
Last refreshed: 1 April 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/NCT06624436.