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Enzyme infusion aimed at taming sepsis enters first human safety trial

NCT ID NCT05453695

Disease control Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests whether an intravenous enzyme called DNase I is safe and feasible for ICU patients with sepsis. Sepsis is a life-threatening response to infection that can damage organs. The study will enroll 36 adults and monitor how many complete the treatment and blood collection as planned. It is a first step to see if this approach is worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DNase I (an enzyme given intravenously)
What this could lead to
If safe and feasible, this could pave the way for a new treatment to reduce organ damage in sepsis.
What could go wrong
This is a very early phase 1 trial with only 36 patients, focused on safety, not effectiveness. It may not show benefit or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Critical Illness infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8L 0A4, Canada

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