NCT05453695

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sepsis
• Critical Illness

Interventions

Type	Name	Description
DRUG	Intravenous DNase I	Dose-escalating intravenous infusion of DNase I

Timeline

• Start date: 2023-01-17
• Primary completion: 2026-05-28
• Completion: 2026-09-30
• First posted: 2022-07-12
• Last updated: 2026-03-03

Locations

1 site across 1 country: Canada