Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Hamilton Health Sciences
RECRUITING
Hamilton
Contact Information
Primary
Alison Fox-Robichaud, MD
afoxrob@mcmaster.ca
905 521 2100
Backup
Patricia Liaw, PhD
Patricia.Liaw@taari.ca
(905) 521-2100
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2025-09
Participants
Target number of participants: 36
Treatments
Experimental: Intravenous DNase I
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)
No_intervention: Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: McMaster University