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Testing Personalized Drug Combination Treatment to Reduce Deaths in Patients with Severe Acute Infections

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study involves patients with severe acute infection, which is a serious condition where harmful germs such as bacteria or viruses invade the body and cause widespread illness that can affect multiple organs. The study will use four different medications that may be given based on individual patient needs: hydrocortisone (a steroid medication that helps reduce inflammation and supports the body's stress response, available as tablets or injection), acetylcysteine (a medication given through a vein that helps protect organs from damage), and ferric derisomaltose (an iron supplement given through a vein to treat low iron levels in the blood). The purpose of the study is to determine if a treatment approach tailored to each patient's specific needs can reduce the number of deaths and shorten the time patients spend in the hospital.

Patients in this study will be adults admitted to the hospital with suspected infection who show signs that their organs are not working properly. They must have been admitted within 72 hours with an infection that doctors expect will require hospital care for more than 24 hours. The study will compare patients who receive individualized treatment based on their specific medical problems against those who receive standard care. The treatments may be given alone or in combination depending on what each patient needs, and the treatment period can last up to 8 days for some medications and 1 day for others.

During the study, doctors will monitor patients closely for any side effects and will track how many days patients are alive and out of the hospital at 14 days and 30 days after joining the study. They will also measure other important outcomes such as survival rates at different time points, whether patients need intensive care, how long they stay in the hospital, their quality of life after six months, and whether they need additional treatments such as breathing support, blood pressure medications, or blood transfusions. The study will also track how long patients need antibiotics and whether their antibiotic treatment needs to be changed or increased.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and enrollment

    Upon admission to the hospital with a severe acute infection, your condition will be assessed. A severe acute infection is a serious infection that affects your body and may impact the function of your organs.

    Your organ function will be evaluated using a scoring system to determine if your condition meets the requirements for participation in this trial.

    Samples will be collected to identify the cause of your infection, and antibiotic treatment will be initiated or continued.

  2. Step 2

    Randomization and treatment assignment

    You will be randomly assigned to receive either the individualized treatment approach or standard care. Random assignment means that a computer system will determine which treatment group you are placed in, similar to flipping a coin.

    If assigned to the individualized treatment group, your specific treatment plan will be determined based on your individual medical condition and test results.

  3. Step 3

    Treatment administration

    Depending on your assigned treatment group and individual needs, you may receive one or more of the following medications:

    Hydrocortisone may be administered either through an intravenous line (directly into your vein) or as tablets taken by mouth. This medication helps reduce inflammation in your body.

    Acetylcysteine may be given through an intravenous line. This medication helps protect your organs and supports your body's response to infection.

    Ferric derisomaltose may be administered through an intravenous line. This is an iron supplement that helps restore iron levels in your blood.

    The specific dosage, frequency, and duration of each medication will be determined by your treating physician based on your individual condition.

  4. Step 4

    Monitoring during hospital stay

    Throughout your hospital stay, your medical team will monitor your condition closely.

    Your organ function, infection status, and response to treatment will be assessed regularly.

    Blood samples will be taken to check for any changes in your liver function, hemoglobin levels (the protein in your blood that carries oxygen), and other important markers.

    Your need for additional support, such as oxygen therapy or medications to maintain blood pressure, will be evaluated and provided as needed.

    The duration and type of antibiotic therapy you receive will be monitored and adjusted as necessary.

  5. Step 5

    Follow-up at 14 days

    At 14 days after enrollment, information will be collected about your recovery progress.

    This includes the number of days you have been alive and out of the hospital.

    Any serious adverse events (unexpected medical problems) that occurred during this period will be documented.

    Information about your intensive care unit admission, if applicable, will be recorded.

  6. Step 6

    Follow-up at 30 days

    At 30 days after enrollment, additional information will be collected about your recovery.

    This includes the number of days you have been alive and out of the hospital.

    Information about your hospital length of stay, antibiotic treatment duration, and any need for respiratory support or blood pressure medications will be recorded.

    Blood test results and any blood transfusions received will be documented.

  7. Step 7

    Follow-up at 180 days

    At 180 days (approximately 6 months) after enrollment, your health status will be assessed.

    You will be asked to complete a questionnaire about your quality of life and general health status.

    Information about your survival will be collected.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older
  • You must have a suspected sudden infection that started within the last 3 days (72 hours) since being admitted to the hospital. This means either samples were taken from your body to check for germs, or you were started on medicines to fight infection called antibiotics
  • You must be admitted to the hospital and expected to stay for more than 24 hours (one full day)
  • You must have a SOFA score of 2 or higher. SOFA stands for Sequential Organ Failure Assessment, which is a scoring system doctors use to measure how well your organs are working. A score of 2 or more means that at least one of your organs is not working as well as it should
  • Your doctor must have a clear medical reason to believe you have an infection based on your symptoms and condition

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria listed, it is not possible to identify specific medical conditions, treatments, or situations that would prevent someone from joining this clinical trial
  • Typically, exclusion criteria might include things like being pregnant, having certain other illnesses, taking specific medications, or having allergies to treatment components, but none of these are specified in the available information
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Investigated drugs

Unfortunately, the provided clinical trial data does not contain specific information about the medications or therapies being tested in this study. The available information only includes the trial title "Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)" and its objective to determine if an individualized treatment strategy can reduce mortality and hospital length of stay for patients with severe acute infections. Without detailed information about the specific medications, therapies, or interventions being used in this trial, I cannot provide descriptions of the treatments involved. To complete this task, additional data about the actual products, drugs, or therapeutic approaches being studied would be needed.

What is already known about the treatment

IMPACT Trial Medications – This clinical trial is investigating an individualized treatment approach for patients suffering from severe acute infections, which are serious conditions where harmful germs invade the body and cause life-threatening illness. The study aims to personalize therapy based on each patient's specific disease characteristics to potentially reduce death rates and shorten the time patients need to stay in hospital. The trial does not specify particular medications but rather focuses on tailoring existing treatments to match individual patient needs based on their body's response to infection. This represents a modern approach in medicine where doctors select and combine therapies specifically for each person rather than using the same treatment for everyone with similar infections.

Investigated diseases

Severe Acute Infection – A severe acute infection is a serious condition where harmful microorganisms such as bacteria, viruses, or fungi invade the body and multiply rapidly, causing significant illness. This type of infection develops quickly and can affect various parts of the body including the lungs, blood, urinary tract, or skin. The body's immune system responds strongly to fight the infection, which can lead to symptoms such as high fever, rapid heart rate, difficulty breathing, and confusion. As the infection progresses, it may cause inflammation throughout the body and can affect multiple organ systems. Patients with severe acute infections often require hospital care and close monitoring. The condition can lead to complications such as sepsis, where the body's response to infection causes widespread inflammation and organ dysfunction.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522215-42-00Estimated enrolment300 patientsSponsorCopenhagen University Hospital

sourced from the EU Clinical Trials Register and site verification

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