In the Netherlands, an average of almost 900 patients with a serious viral pneumonia such as influenza (flu) are admitted to the ICU every year
On average, one of every five patients admitted to the intensive care unit (ICU) with severe pneumonia due to influenza dies. To reduce this relatively high risk of death, a new study is starting under the leadership of the UMC Utrecht. Researchers wonder whether drugs that were previously successful in treating ICU patients with severe COVID-19 are also effective in ICU patients with severe influenza pneumonia. ZonMw has made a subsidy of more than 2.1 million euros available for this study.
In the Netherlands, an average of almost 900 patients with a serious viral pneumonia such as influenza (flu) are admitted to the ICU every year. On average, one of every five of these patients dies. The inflammatory response that arises is very similar to the so-called ‘hyperinflammation’ response that was also seen in seriously ill COVID-19 patients. Although influenza and COVID-19 are different diseases, the clinical symptoms of the sickest patients, those who end up in the ICU, are similar. Because there is no proven effective treatment for severe influenza, researchers wondered whether drugs that were successful in severe COVID-19 might also work for severe influenza. To answer this important question, ZonMw (via the Good Medicine Use programme) has made a subsidy of more than 2.1 million euros available to the Dutch IMPRINT consortium for this study.
Goal: less mortality
IMPRINT (which stands for ‘Immune Modulation Platform for Influenza Treatment’) is investigating for the first time whether treatment with tocilizumab or baricitinib, both of which have proven effective in seriously ill patients with COVID-19, is also effective in severe pneumonia due to influenza. If successful, such treatment could prevent illness and death, prevent the spread of the virus and reduce the pressure on scarce ICU beds. Even if a new pandemic were to arise due to an influenza virus, it is important to know whether these remedies work.
Main applicant and coordinator of the IMPRINT study Dr. Lennie Derde (intensivist at the UMC Utrecht) explains: “In this study we investigate whether additional treatment with tocilizumab, or baricitinib, or the current standard care gives the best chance of survival in adult patients. who have been admitted to the ICU with severe pneumonia due to influenza. We hope that one or both agents will be better than if no specific immunomodulation is used.”
Broad cooperation
Within the IMPRINT consortium, the UMC Utrecht collaborates with several academic and peripheral hospitals, the Dutch Association for Intensive Care, the NICE Foundation (the Dutch IC registration), patient representatives via FCIC/IC-CONNECT, and the Ecraid research network to develop the next 4 years. to give patients the opportunity to participate in this study. The IMPRINT study is being conducted in collaboration with the international REMAP-CAP study, which has played an important role in finding effective treatments against the coronavirus. This collaboration allows the required number of patients to be reached more quickly. The study will be integrated within the Influenza Immune Modulation Domain of REMAP-CAP, which is expected to include approximately 700 patients in the Netherlands.
Innovative study model
The IMPRINT study is conducted as a so-called adaptive platform trial (APT), an innovative study model in which each of the three arms is determined whether they are better, worse, or as good as the other arms. In clinical drug research, the randomized controlled trial (RCT) is the gold standard method to demonstrate the effect of a treatment. However, RCTs are expensive, take a lot of time and can only answer a few research questions per study. To overcome these limitations, APTs have been developed. APTs can answer multiple research questions simultaneously using a pre-established infrastructure and the use of a basic protocol.
As a study progresses and more patients participate, the results can be analyzed within an APT at specific times. Researchers can then determine whether there is sufficient data to determine – according to predefined rules – whether the research question has been answered. If a researched treatment turns out to be better than the standard treatment, the treatment in question can become the new standard. New treatments may also be added to the study. A new potential treatment can therefore be investigated relatively quickly and cost-effectively through an APT.
Source: UMC Utrecht
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