Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Acetylcysteine for Adults with Acute Infection or Sepsis and Liver Dysfunction

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying adults with acute infection or sepsis who also have signs of liver dysfunction, which means the liver is not working properly. The treatment being tested is N-acetylcysteine, also called acetylcysteine, given as an intravenous infusion into a vein. The study is being done to see whether this treatment can improve recovery and reduce time spent in the hospital.

People in the study are assigned by chance to receive either acetylcysteine or sodium chloride. The treatment is given during the hospital stay, and the study then follows the course of recovery over the next days and months. The study looks at how well participants do after treatment, including survival and length of hospital stay, without using complicated procedures in the description.

Sepsis is a serious reaction to infection that can quickly become life-threatening. Liver dysfunction means the liver is injured or not working normally. The purpose of this study is to assess whether acetylcysteine can help adults with severe infection and liver dysfunction recover better.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and first infusion

    After joining the study, you are assigned by chance to one of two treatment groups. This assignment is called randomization, which means the treatment group is chosen randomly.

    If you are placed in the active treatment group, you receive acetylcysteine by intravenous infusion (medicine given through a vein) at a dose of 200 mg/kg.

    If you are placed in the comparison group, you receive sodium chloride by intravenous infusion at a dose of 500 ml. Sodium chloride is a salt solution used here as a placebo, which means it does not contain the study medicine.

    The trial is blinded, which means that the treatment assignment is kept hidden during the study.

  2. Step 2

    Treatment period through day 14

    Your treatment is followed from the time of randomization until day 14.

    During this period, the study records how many days you are alive and out of the hospital.

    The study also records whether you have one or more serious adverse events within 14 days. A serious adverse event is a harmful medical problem that is severe.

    The study records whether you are admitted to an ICU within 14 days. ICU means intensive care unit, a hospital area for very close monitoring and treatment.

    The study records the duration of antibiotic therapy from randomization to day 14. Antibiotics are medicines used to treat infections.

    The study records the time to clinical stability, which means the time until your condition becomes medically stable.

  3. Step 3

    Follow-up to day 180

    Your progress is followed until day 180 after randomization.

    The study records all-cause mortality at day 180, which means whether you have died from any cause by that time.

    The study records health-related quality of life at day 180 using the EQ-5D-5L index values. EQ-5D-5L is a questionnaire that measures general health and daily well-being.

    The study records how many days you are alive and out of the hospital from randomization to day 180.

Who can join the trial?

3 criteria

  • Be 18 years of age or older.
  • Have a documented clinical suspicion of infection, meaning the medical team has recorded that an infection is likely based on the patient's symptoms, examination, or test results.
  • Have a MELD score of 9 or higher. The MELD score is a medical score used to measure how well the liver is working; a higher score means more liver dysfunction.

Who cannot join the trial?

15 criteria

  • Being admitted to the hospital for more than 24 hours before being assigned to the study.
  • Having a documented or strongly suspected bile duct obstruction, which means a blockage in the tubes that carry bile from the liver.
  • Having refractory circulatory shock, meaning a very severe drop in blood flow that does not improve with treatment.
  • Being unable to give informed consent, which means being unable to understand the study well enough and agree to take part.
  • Being pregnant.
  • Being unable to read and understand Danish well enough to give valid consent and complete the study tests.
  • Being admitted against the person’s will under psychiatric law, meaning compulsory psychiatric admission.
  • Having any other condition that the study doctor thinks could affect safety or the reliability of the study results, such as:
    • Severe coagulopathy, meaning a serious problem with blood clotting.
    • Uncontrolled bleeding.
    • Diabetic ketoacidosis, a dangerous complication of diabetes caused by very high blood acidity.
    • Expected to start palliative care within 48 hours after being assigned to the study, meaning care focused on comfort rather than recovery.
    • Already receiving nitroglycerin, a medicine often used for chest pain and heart problems.
    • Having had any previous severe anaphylaxis, which means a very serious allergic reaction.
    • Having a known allergy to N-acetylcysteine.
    • Already being treated with N-acetylcysteine at the time of study assignment.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Acetylcysteine is the active treatment being tested in this trial. It is given through a vein and is being studied in adults with acute infection or sepsis who also have signs of liver problems. The trial is looking to see whether it can help lower the risk of death and shorten the time spent in the hospital.

What is already known about the treatment

  • Acetylcysteine

    Acetylcysteine is given by intravenous infusion, which means it is delivered slowly into a vein by a healthcare professional. It is a well-known medicine in medical practice and research, and it is used in hospitals for several purposes, especially to help protect the liver and to loosen thick mucus in the lungs. In this trial, it is being studied for adults with acute infection or sepsis and liver problems, because it may help the body cope with severe illness by restoring a natural antioxidant called glutathione and reducing harmful stress inside cells. It belongs to the class of mucolytic and antioxidant medicines, and it also has a liver-protective role.

  • Sodium chloride

    Sodium chloride is given by intravenous infusion, meaning it is infused slowly into a vein as a liquid solution. It is a very common and well-established substance in medicine and medical literature, widely used as a salt solution for hydration, as a vehicle for other medicines, and as a placebo in clinical trials. In this study, it serves as the placebo, so it does not have a direct treatment effect on infection or sepsis. Pharmacologically, it is a simple salt solution that helps maintain fluid balance in the body and does not act through a specific drug target at the molecular level.

Investigated diseases

  • Acute Infection

    An acute infection is a sudden infection caused by bacteria, viruses, fungi, or other germs that develops quickly over a short period. It usually begins with a rapid increase in symptoms such as fever, pain, swelling, or weakness, depending on the body part involved. The illness often progresses over hours to days and may remain limited to one area or spread to other parts of the body if it becomes more severe.

  • Sepsis

    Sepsis is a serious body-wide response to an infection in which the immune system reacts in an abnormal and overwhelming way. It usually develops from an infection that starts in one place and then triggers widespread inflammation throughout the body. As it progresses, it can cause worsening weakness, confusion, breathing problems, and problems with blood flow and organ function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525895-25-00Estimated enrolment360 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.