RecruitingPHASE1INTERVENTIONAL

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

This study, called IDEALSepsisI, is investigating a new treatment named DNase I for patients in intensive care who have a serious condition called sepsis. Sepsis happens when the body's reaction to an infection damages its own tissues and organs. In sepsis, certain body defences can overreact, potentially causing harm. DNase I is a medicine designed to help break down these harmful defences. This is an early 'Phase I' study, meaning we are mainly focused on finding out if DNase I is safe to use in people, what the right dose might be, and if it's practical to give it. The information we learn here will help decide if future, larger studies are needed to see how effective DNase I is in treating sepsis and helping patients get better.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

McMaster University

Enrolment target

Start

17 Jan 2023

Estimated completion

30 Sep 2026

Sepsis Critical Illness

What is this study about?

When someone has sepsis, which is a very serious reaction to an infection, their body's immune system can sometimes go into overdrive. Part of this overreaction involves tiny fibres called 'NETs' (Neutrophil Extracellular Traps). While NETs usually help fight infections, too many of them can start to cause problems, like blocking small blood vessels and potentially damaging organs.

This study is testing a new medicine called DNase I. Think of DNase I as a special enzyme – like a tiny pair of scissors – that can break down these problematic NETs. By doing so, we hope it might help prevent some of the organ damage that can happen in sepsis. We've seen promising results in lab tests and animal studies, and now we need to see how it works in people.

This is a 'Phase I' study, which means it’s one of the first times this treatment is being studied in humans. Our main goals are to make sure the treatment is safe, to find the best dose to give, and to see if it’s practical to use in patients who are very unwell in intensive care. We will also be looking at how it affects the body's clotting system and the NETs themselves, and collecting samples for future research.

Key takeaways

This study is for people extremely unwell with sepsis in intensive care.
It's testing a new medicine, DNase I, to see if it's safe and helps with sepsis.
DNase I aims to break down body defence fibres that can cause organ damage.
This is an early-stage 'safety and dosing' study, not yet focused on cure.
Participation involves receiving the medicine and close monitoring by medical staff.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have been admitted to the intensive care unit (ICU) within the last two days. You would also need to have a suspected or confirmed infection that caused your admission and show signs of organ problems because of the infection. Doctors expect you to stay in the ICU for at least another three days.

There are several reasons why someone might not be able to join. For example, if you or your family cannot give consent, or if you have another type of serious shock that isn't related to infection. Also, if there's a significant risk of bleeding, such as recent surgery, active bleeding, or certain brain conditions, you wouldn't be able to participate. This includes conditions like severe head trauma within the last three months or if you already have a problem with blood clotting.

You also wouldn't be able to join if you're already receiving DNase I through an inhaler, if you have a terminal illness with less than three months to live, or if you are pregnant or breastfeeding. The study is open to both men and women, between the ages of 18 and 100.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been admitted to intensive care for an infection in the last 2 days?
Are your doctors expecting you to need intensive care for at least 3 more days due to organ problems from the infection?
Do you have no significant risk of bleeding or certain brain conditions?
Are you not pregnant or breastfeeding, and not receiving DNase I through an inhaler?
Are you able to give consent, or does a relative have the authority to do so?

Answer every question to see your result.

What does participation involve?

If you or your family decide to take part in this study, you would receive the study medicine, DNase I, through a drip into your vein while you are in the intensive care unit. The doctors and nurses would carefully monitor you throughout your stay, paying close attention to how you are responding to the treatment and any possible side effects. They would also take regular blood samples to check how the medicine is affecting your body, including your blood clotting and immune system.

Because this is a dose-finding study, some patients might receive a slightly different dose from others as we work out the safest and most effective amount. The medical team would also keep a close eye on your overall condition, including how your organs are functioning and how long you stay in the ICU. The duration of your participation would depend on your medical needs and how long you require intensive care.

Potential risks and benefits

Taking part in this study might offer some potential benefits, as DNase I is a new treatment that could help reduce harmful effects of sepsis. However, because this is an early-stage study, we don't yet know if it will definitely help you feel better or improve your condition. There are potential risks associated with any new medication, and we will be carefully monitoring for any side effects. These could include unexpected bleeding since DNase I affects processes in the body related to clotting. Your medical team will explain all known and potential risks honestly. You are always free to discuss your participation with your medical team and can withdraw from the study at any time without it affecting your medical care.

Locations (1)

Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is sepsis?

Sepsis is a serious condition where your body's response to an infection damages its own tissues and organs. It needs urgent medical attention.

What is DNase I?

DNase I is a study medicine that aims to break down tiny fibres in the blood ('NETs') that can cause harm in sepsis, potentially protecting organs.

Is DNase I currently available for sepsis?

No, DNase I is not a standard treatment for sepsis. This is a research study to see if it is safe and effective.

What does 'Phase I' mean?

Phase I means this is an early study, primarily focused on checking the safety of the treatment in people and finding the right dose, rather than how well it cures the illness.

Will I get better if I join this study?

We hope to learn if DNase I can help, but we can't guarantee you will get better by joining. That's what we are trying to find out.

How to find out more

Alison Fox-Robichaud, MD

afoxrob@mcmaster.ca 905 521 2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.