RecruitingOBSERVATIONAL

ARTICE® Real Data Collection & Observational Trial, Phase 4 Study

This is a study collecting real-life information about a treatment called ARTICE®. It’s for adults aged 18 and older who are already in intensive care and are receiving ARTICE® because they have sepsis, a serious body reaction to infection, or septic shock. The main goals are to gather data on how ARTICE® is used in practice, see if it is effective in helping patients get better, and understand if certain groups of people respond differently or have any side effects. Researchers will be looking at changes in a score called the SOFA score, which measures how well different body organs are working, to see if patients improve over time after receiving ARTICE®.

At a glance

Status

Recruiting

Sponsor

Artcline GmbH

Enrolment target

200

Start

25 Sep 2025

Estimated completion

01 Dec 2027

Sepsis Septic Shock Immunoparalysis in Septic Shock

What is this study about?

This study is about a treatment called ARTICE®, which is being used for people who are very unwell with sepsis or septic shock. Sepsis happens when your body has an extreme response to an infection, which can be life-threatening. Septic shock is an even more severe form where your blood pressure drops dangerously low.

The main idea of this study is to collect information from people who are already receiving the ARTICE® treatment as part of their regular care. It's like gathering 'real-world' data to understand how the treatment works for different patients in hospitals. They want to see if ARTICE® helps people get better, and if it's safe to use.

The doctors and researchers involved will also try to identify if certain groups of people respond better or worse to ARTICE®, looking at things like their overall health and other conditions they might have. They'll be tracking changes in a scoring system called the SOFA score, which helps doctors understand how different organ systems in the body are functioning, to see if patients improve after treatment with ARTICE®.

Key takeaways

This study is collecting real-life information about a treatment called ARTICE®.
It's for adult patients in intensive care with sepsis or septic shock.
Participation involves sharing medical information, not receiving new treatments.
The goal is to understand how well ARTICE® works and for whom.
Your health records will be used to track changes in illness severity.
Your medical care will not change if you participate.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older. The main requirement is that you are already receiving the ARTICE® treatment while you are in the intensive care unit (ICU).

There are no other specific exclusion criteria listed, which means if you meet the age and treatment criteria, you would generally be considered for the study.

Ultimately, your doctors will decide if this study is suitable for you based on your medical condition and the treatment you are receiving.

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?
Are you in an intensive care unit (ICU)?
Are you currently receiving ARTICE® treatment?
Have you been diagnosed with sepsis or septic shock?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it means that information about your health and your ARTICE® treatment will be collected by the researchers. This study is observational, which means it looks at treatments people are already receiving as part of their standard care. You won't be given any new or different medicines or treatments just for the study.

Your doctors will continue to look after you as normal. The study will involve collecting data from your medical records, including details about your illness, the ARTICE® treatment you receive, and how your health changes over approximately seven days. There are no extra visits or procedures required specifically for this study, as all information comes from your routine hospital care.

Potential risks and benefits

Since this is an observational study, you will not be given any new treatments or procedures specifically for the study. This means there are no additional risks to your health that come directly from participating in the study itself, beyond those associated with your ongoing medical care for sepsis and the ARTICE® treatment you are already receiving. The potential benefit is that the information gathered from your experience, combined with that of others, could help doctors better understand the ARTICE® treatment, improving care for future patients. You have the right to withdraw your consent to have your data included in the study at any time, without affecting your medical care.

Locations (1)

Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Verified postcode
Magdeburg, Germany· Recruiting

Common questions

What is ARTICE®?

ARTICE® is a treatment given to people with serious conditions like sepsis or septic shock. This study is trying to understand more about how it works in real patients.

Will I get extra treatments or medicines if I join?

No, this study only collects information about the treatment you are already receiving as part of your standard hospital care. You won't get anything extra just for the study.

Who can be in this study?

Adults aged 18 or older who are in intensive care and are already being treated with ARTICE® for sepsis or septic shock can be included.

What kind of information will be collected?

Researchers will gather details from your medical records about your condition, your ARTICE® treatment, and how your health changes over time, including scores that measure organ function.

Can I decide not to be in the study later?

Yes, you can choose to withdraw your consent at any time, which means your information will no longer be used in the study. This will not affect your medical care in any way.

How to find out more

Jens Altrichter, Dr. med.

jens.altrichter@artcline.de +49 381 440 703 0 Official trial record

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