SepsisPhase 1IDEALSepsisINCT05453695
Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)
A Phase 1 study testing Intravenous DNase I in people with Sepsis and Critical Illness, run by McMaster University at 1 site in Canada.
Trial summary
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Critical Illness
- What is being tested?
- Intravenous DNase I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2023to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 0A4
Alison E Fox-Robichaud, MD
About this study
Official title: Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients
Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.
Read the 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
- - To determine the safety, feasibility and maximum tolerated dose (MTD) of using DNase I in septic patients
- - To evaluate clinical endpoints common in the critically ill such as organ dysfunction severity and trajectory, ICU length of stay, and mortality.
- - To describe the effects of DNase I on blood coagulation and NETs release
- - To collect samples for future studies on coagulation and immune function in sepsis.
- Conditions
- Sepsis, Critical Illness
- Being tested
- Intravenous DNase I
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous DNase IDrug
Dose-escalating intravenous infusion of DNase I
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients recruited per month from the start of the study
Number of patients recruited per month
Measured: up to 24 months
Number of patients who completed the protocol
The ability to complete study infusion and blood collection as prescribed
Measured: up to 7 days
Secondary outcomes (7)
Sequential Organ Failure Assessment (SOFA) score
Quantitative variable: Maximal score of SOFA (Sequential Organ Failure Assessment) will be recorded; Value range 0-24 points
- Delta SOFA score, defined as maximum versus minimum SOFA during ICU stay
- Change in SOFA score within 48 hours
Measured: Baseline to Day 10
Organ support free days
Increase of three or more days free from vasopressor therapy, invasive mechanical ventilation or renal replacement therapy.
Measured: at Day 28
Duration of ICU admission
Number of days since admission to discharge from the ICU
Measured: up to 9 months
Time to Hospital discharge
Time elapsed between enrolment into the study (at admission), and discharge
Measured: up to 90 days
Mortality at Day 90
Number of patients alive at day 90
Measured: up to day 90
European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Average or median EQ-5D-5L score
Measured: At day 90
Collection of Research Biomarkers related to inflammation and coagulation
Number of patients with all sets of biomarkers
Measured: up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start17 Jan 2023
- Primary completion28 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453695
- Sponsor's protocol ID
- IDEALSepsisI
- Acronym
- IDEALSepsisI
- Status last verified
- Apr 2025
- First submitted
- 24 Jun 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40705350
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients
- ClinicalTrials.gov ID
- NCT05453695
- Acronym / sponsor ID
- IDEALSepsisI / IDEALSepsisI
- Conditions
- Sepsis, Critical Illness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- - To determine the safety, feasibility and maximum tolerated dose (MTD) of using DNase I in septic patients
- - To evaluate clinical endpoints common in the critically ill such as organ dysfunction severity and trajectory, ICU length of stay, and mortality.
- - To describe the effects of DNase I on blood coagulation and NETs release
- - To collect samples for future studies on coagulation and immune function in sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous DNase I | Experimental | Drug: Intravenous DNase IWe 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) |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Receiving DNase I by inhalation
- Terminal illness with a life expectancy of fewer than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous DNase IDose-escalating intravenous infusion of DNase I | Drug | Intravenous DNase I |
Primary outcome
Number of patients recruited per month from the start of the study
Time frame: up to 24 months
Number of patients recruited per month
Number of patients who completed the protocol
Time frame: up to 7 days
The ability to complete study infusion and blood collection as prescribed
7 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score
Time frame: Baseline to Day 10
Organ support free days
Time frame: at Day 28
Duration of ICU admission
Time frame: up to 9 months
Time to Hospital discharge
Time frame: up to 90 days
Mortality at Day 90
Time frame: up to day 90
European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Time frame: At day 90
Collection of Research Biomarkers related to inflammation and coagulation
Time frame: up to day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Derived from this study: PubMed 40705350Sharma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous DNase I in people with Sepsis and Critical Illness, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Fox-Robichaud, MD (905 521 2100 ext. 4074, afoxrob@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients recruited per month from the start of the study (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.