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New treatment option for Sepsis
Official title Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
ClinicalTrials.gov ID: NCT05453695
What this study is testing
What is Intravenous DNase I?
Intravenous DNase I is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sepsis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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 likely can't join 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...
- 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
See the full eligibility criteria
- 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
- 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
- Terminal illness with a life expectancy of fewer than three months
- Pregnant and/or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.