Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

NCT05453695 | Recruiting Phase 1 DMC

• 1 other identifier: IDEALSepsisI
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis; Critical Illness

Outcome Measures

Primary Outcomes (2)

• Number of patients recruited per month from the start of the study

  Number of patients recruited per month

  up to 24 months

• Number of patients who completed the protocol

  The ability to complete study infusion and blood collection as prescribed

  up to 7 days

Secondary Outcomes (7)

• Sequential Organ Failure Assessment (SOFA) score

  Baseline to Day 10

• Organ support free days

  at Day 28

• Duration of ICU admission

  up to 9 months

• Time to Hospital discharge

  up to 90 days

• Mortality at Day 90

  up to day 90

Study Arms (2)

Intravenous DNase I

EXPERIMENTAL

We will enroll up to 36 Participants; each is receiving repeated unit doses of DNase I, BID, delivered by IV infusion over 3 or 7 consecutive days (12 +/- 1 hour apart) according to the following dose-escalation schedule with up to 6 Participants per dose panel. * Panel 1: 25 µg/kg, BID for 3 days (cumulative dose: 150 µg/kg) * Panel 2: 25 µg/kg, BID for 7 days (cumulative dose: 350 µg/kg) * Panel 3: 125 µg/kg, BID for 3 days (cumulative dose: 750 µg/kg) * Panel 4: 125 µg/kg, BID for 7 days (cumulative dose: 1750 µg/kg)

Drug: Intravenous DNase I

Control

NO INTERVENTION

We will also enroll 12 septic Participants who do not receive intravenous DNase I (as Comparator Group). These patients will be recruited contemporaneously based on the same inclusion and exclusion criteria.

Interventions

Intravenous DNase I DRUG

Dose-escalating intravenous infusion of DNase I

Intravenous DNase I

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 0A4, Canada

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Alison Fox-Robichaud, MD

CONTACT

905 521 2100; afoxrob@mcmaster.ca

Patricia Liaw, PhD

CONTACT

(905) 521-2100; Patricia.Liaw@taari.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 12, 2022
• Study Start: January 17, 2023
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)