NCT05453695 Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
| NCT ID | NCT05453695 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | McMaster University |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2026-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2023-01-17 with a primary completion date of 2026-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
Eligibility Criteria
Inclusion Criteria: 1. Age of ≥18 years 2. Admitted to the ICU in the last 48 hours 3. Suspected or proven infection as the admitting diagnosis 4. A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline 5. Expected to remain in the ICU for ≥ 72 hours Exclusion Criteria: 1. No consent/inability to obtain consent from a substitute decision-maker 2. Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock 3. 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 4. Receiving DNase I by inhalation 5. Terminal illness with a life expectancy of fewer than three months 6. Pregnant and/or breastfeeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05453695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05453695 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05453695 currently recruiting?
Yes, NCT05453695 is actively recruiting participants. Contact the research team at afoxrob@mcmaster.ca for enrollment information.
Where is the NCT05453695 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT05453695 clinical trial?
NCT05453695 is sponsored by McMaster University. The trial plans to enroll 36 participants.