Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 7:51 AM
Study NCT ID:
NCT05453695
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2022-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEALSepsisI
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: