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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

IDEALSepsisI Trial 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.Check my eligibility

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.See study design

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.

IDEALSepsisI Trial 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.

IDEALSepsisI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Number of patients who completed the protocol

Secondary outcome measures

Blood coagulation tests

Duration of ICU admission

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

+4 more

IDEALSepsisI 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

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,280 Total Patients Enrolled

3 Trials studying Sepsis

1,705 Patients Enrolled for Sepsis

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,478 Total Patients Enrolled

9 Trials studying Sepsis

6,744 Patients Enrolled for Sepsis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this medical study at present?

"As per the information available on clinicaltrials.gov, this particular medical trial is not currently accepting new participants. The initial posting of this study occurred on January 17th, 2023 and it was last modified on January 17th, 2024. However, there are presently 323 other active trials seeking eligible candidates for enrollment."

Answered by AI

What is the primary goal of conducting this clinical trial?

"The primary objective of this trial, which will span approximately 24 months, is to determine the number of patients who successfully completed the protocol. Secondary outcomes include assessing various research biomarkers associated with inflammation and coagulation by determining the number of patients who have a complete set of biomarkers available. Additionally, quantitative variables such as the maximum Sequential Organ Failure Assessment (SOFA) score within a given timeframe (ranging from 0-24 points), delta SOFA score comparing the highest and lowest values during ICU stay, change in SOFA score within 48 hours, and organ support-free days (defined as an increase of three or more"

Answered by AI

What are the potential risks associated with intravenous administration of DNase I in individuals?

"Since this is a Phase 1 trial, the available data supporting both safety and efficacy for Intravenous DNase I is limited. Consequently, our team at Power rates its safety as 1 on a scale of 1 to 3."

Answered by AI

Am I eligible to be a part of this medical study?

"This investigation is accepting 36 individuals, ranging from 18 to 100 years old, who presently suffer from sepsis. In addition to meeting the minimum age requirement, participants must satisfy the subsequent conditions: Admittance to an intensive care unit within the previous 48 hours; Diagnosis upon admission indicating a suspected or confirmed infection; A sequential (sepsis) organ function assessment (SOFA) score that exceeds baseline by at least ≥2 points; Anticipated stay in the intensive care unit for a duration of no less than ≥72 hours."

Answered by AI

Is it permissible for individuals below the age of 18 to participate in this medical study?

"To be eligible for participation in this research, individuals must have attained the age of 18 and should not exceed a maximum age threshold of 100."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

2023. "Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453695.

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