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Enzyme

Intravenous DNase I for Sepsis (IDEALSepsisI Trial)

Phase 1

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of ≥18 years

Suspected or proven infection as the admitting diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and feasibility of giving a medication called IV DNase I to ICU patients with sepsis.

Who is the study for?

Adults over 18, recently admitted to the ICU with suspected or confirmed infection leading to sepsis and a SOFA score ≥2 above baseline. They should expect to stay in the ICU for at least 72 hours. Specific details on who can't join are not provided.

What is being tested?

The trial is testing the safety and how feasible it is to use Intravenous DNase I in patients with sepsis in intensive care. It's an early-stage study that gradually increases doses to find out what's safe.

What are the potential side effects?

Since this is a Phase I trial primarily focused on safety, specific side effects of IV DNase I are not listed but may include reactions related to immune response or infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was admitted to the hospital because of a suspected or confirmed infection.

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My illness has worsened by at least 2 points on the SOFA scale.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients recruited per month from the start of the study

Number of patients who completed the protocol

Secondary study objectives

Blood coagulation tests

Duration of ICU admission

European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intravenous DNase IExperimental Treatment1 Intervention

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)

Group II: ControlActive Control1 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.

0 / 3Eligibility criteria met