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Recruiting NCT05453695

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

Phase I Interventional Sepsis Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous DNase I.
Who it may be relevant to
Registry conditions: Sepsis, Critical Illness. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients

Overview

Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.

Detailed description

In sepsis, the release of 'neutrophil extracellular traps' (NETs) by activated neutrophils may contribute to organ damage by acting as scaffolds that trap blood cells and fibrin clots. Excessive NET formation can occlude the vasculature, promoting thrombosis and tissue hypoperfusion. This is a trial on a novel IV therapy for septic patients that shows promise in multiple animal models of sepsis. The therapy, DNase I, is an enzyme that helps to dismantle NETs by digesting cell-free DNA (cfDNA), the major structural component of NETs. The objective of this study is to conduct a Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients. The results of this study may justify a future Phase II trial of the efficacy and safety of DNase I for critically ill patients with sepsis.

This trial proposes

1. \- To determine the safety, feasibility and maximum tolerated dose (MTD) of using DNase I in septic patients 2. \- To evaluate clinical endpoints common in the critically ill such as organ dysfunction severity and trajectory, ICU length of stay, and mortality. 3. \- To describe the effects of DNase I on blood coagulation and NETs release 4. \- To collect samples for future studies on coagulation and immune function in sepsis.

Interventions

  • Drug Intravenous DNase I
    Dose-escalating intravenous infusion of DNase I

Primary outcome measures

  • Number of patients recruited per month from the start of the study [Time frame: up to 24 months]
  • Number of patients who completed the protocol [Time frame: up to 7 days]
Secondary outcome measures (7)
  • Sequential Organ Failure Assessment (SOFA) score [Time frame: Baseline to Day 10]
  • Organ support free days [Time frame: at Day 28]
  • Duration of ICU admission [Time frame: up to 9 months]
  • Time to Hospital discharge [Time frame: up to 90 days]
  • Mortality at Day 90 [Time frame: up to day 90]
  • European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score [Time frame: At day 90]
  • Collection of Research Biomarkers related to inflammation and coagulation [Time frame: up to day 14]

Eligibility criteria

Inclusion criteria

  • Age of ≥18 years
  • Admitted to the ICU in the last 48 hours
  • Suspected or proven infection as the admitting diagnosis
  • A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline
  • Expected to remain in the ICU for ≥ 72 hours

Exclusion criteria

  • No consent/inability to obtain consent from a substitute decision-maker
  • Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock
  • Have a significant risk of bleeding as evidenced by one of the following:
  • Surgery requiring general or spinal anesthesia within 24 hours before enrolment
  • The potential need for surgery in the next 24 hours
  • Evidence of active bleeding
  • A history of severe head trauma requiring hospitalization
  • Intracranial surgery, or stroke within three months before the study
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system
  • A history of congenital bleeding diatheses
  • Gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed
  • Trauma is considered to increase the risk of bleeding
  • Presence of an epidural catheter
  • Need for therapeutic anticoagulation
  • Receiving DNase I by inhalation
  • Terminal illness with a life expectancy of fewer than three months
  • Pregnant and/or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Hamilton Health Sciences — Hamilton

Publications

  • Sharma N, Dwivedi DJ, Fux L, Hayon Y, Ruderfer I, Nataf Y, Cani E, Liaw PC. Intravenous Delivery of Long-Acting Dnase I (PRX-119) In a Murine Model of Polymicrobial Abdominal Sepsis. Shock. 2026 Jan 1;65(1):76-84. doi: 10.1097/SHK.0000000000002666. Epub 2025 Jul 8. PMID 40705350

Identifiers

NCT: NCT05453695 · IDEALSepsisI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗