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NCT03332225: PROVIDE
A Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis
Phase 2 trial testing Anakinra in Sepsis in 36 participants. Completed in 31 December 2019.
31 December 2019
Quick facts
| Lead sponsor | Hellenic Institute for the Study of Sepsis |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 15 December 2017 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 13 locations across Greece |
Drugs / interventions tested
- Anakinra (ANAKINRA) — full drug profile →
- Recombinant human interferon-gamma — full drug profile →
- Placebo
Conditions studied
- Sepsis — all drugs for Sepsis →
- Macrophage Activation Syndrome — all drugs for Macrophage Activation Syndrome →
Sponsor
Hellenic Institute for the Study of Sepsis
Who can join
18 and older, any sex, with Sepsis or Macrophage Activation Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to conduct one RCT of personalized immunotherapy in sepsis targeting patients who lie either on the predominantly hyper-inflammatory arm or on the predominantly hypo-inflammatory arm of the spectrum of the host response. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be randomly allocated to placebo or immunotherapy treatment according to their needs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03332225
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anakinra
Trials testing the same drug.
- NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra · Phase 2 · not yet recruiting
- NCT07281027 — COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" · Phase 3 · not yet recruiting
- NCT07191444 — A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease · recruiting
- NCT06666335 — A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF · Phase 4 · not yet recruiting
- NCT06697431 — Non Inferiority KawasakI Trial With Anakinra · Phase 4 · 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
- NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
- 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 Hellenic Institute for the Study of Sepsis trials
Trials by the same sponsor.
- NCT06608849 — The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acut · recruiting
- NCT06601998 — Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19. · recruiting
- NCT07073456 — Viscoelastic Coagulation for Early Sepsis Detection · recruiting
- NCT06294600 — Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) · Phase 3 · recruiting
- NCT06141395 — NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification · completed
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 NCT03332225 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hellenic Institute for the Study of Sepsis
- Last refreshed: 29 July 2020
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/NCT03332225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing