24 July 2026
News
What if every patient with sepsis—a severe condition responsible for millions of deaths each year—could receive treatment tailored to their specific profile? For the first time, an international adaptive clinical trial is launching on July 24 to improve patient care: PALETTE (Precision medicine Adaptive pLatform triaL for sEpsis and infecTious Treatable traits Evaluation), led by IHU SEPSIS and sponsored by AP-HP, in collaboration with the F-CRIN-accredited CRICS-TRIGGERSEP and RENARCI networks, an infrastructure supported by Inserm. Using a platform-based design, this trial aims to simultaneously test several treatments targeting a specific biological signature for each patient—child or adult—with sepsis. With PALETTE, new therapeutic approaches to combat sepsis—recognized by the WHO as a global health priority*—combining scientific innovation and personalized medicine, could be developed.
Sepsis: A Major, Little-Known Threat
Every year, worldwide, approximately 166 million people are affected by sepsis, an abnormal immune response to an infection that can lead to life-threatening multi-organ failure. Against a backdrop of growing antimicrobial resistance, this condition is responsible for 21 million deaths per year*, more than HIV, breast cancer, or malaria.
In France, sepsis affects approximately 240,000 people each year, causes about 80,000 deaths, and leaves more than one in two patients with severe physical, psychological, and social sequelae.
A Medical Turning Point: Precision Medicine
Sepsis presents in a wide variety of forms, making it unlikely that a single treatment will be effective for all patients. To address this, the IHU SEPSIS and the AP-HP—respectively the world’s leading institute dedicated to the fight against sepsis and Europe’s leading university hospital—in partnership with the CRICS‑TRIGGERSEP network, a European network specializing in sepsis research, with support from the infectious disease research network RENARCI and F-CRIN, are launching PALETTE: an innovative, adaptive, and Bayesian platform trial for sepsis.
PALETTE: An Innovative Trial
Coordinated by Prof. Djillali Annane, an intensive care physician at Raymond Poincaré Hospital in Garches (AP-HP), director of the IHU, founding member of the CRICS-TRIGGERSEP network, and a pioneer in clinical research on sepsis, PALETTE is an adaptive platform trial that relies on the use of treatable features to rapidly tailor treatments to each patient’s specific needs.
Its innovation lies in the identification of patient profiles based on parameters specific to each patient, using algorithms and/or the latest medical knowledge. These profiles make it possible to better predict the response to a given treatment, ensuring that every child or adult with sepsis receives individualized care, with the goal of making treatment more effective and better tolerated.
PALETTE will also make it possible to evaluate multiple treatments simultaneously to guide future studies toward the most promising avenues. In the field of immunity, several treatments aimed at better controlling inflammation will thus be evaluated. These include drugs that target key mechanisms of the immune response, such as tocilizumab, baricitinib, and anakinra. Other approaches designed to stimulate or modulate the immune system will also be studied, such as filgrastim or interferon gamma-1b, as well as plasma exchange techniques to remove certain molecules involved in inflammation. Corticosteroids, the standard-of-care medications for treating inflammation, will also be used according to personalized strategies, notably hydrocortisone and fludrocortisone. Finally, to correct blood clotting disorders that may accompany these conditions, several treatments will be evaluated. Some are already widely used in medical practice, such as heparins (unfractionated heparin and low-molecular-weight heparins) or certain plasma-derived products. Other more targeted treatments, such as thrombomodulin, sivelestat, or plasminogen, may also be offered in the future depending on the biological profile of patients, whether children or adults. PALETTE will also enable the rapid integration of treatment evaluations in the event of a new pandemic, taking into account the lessons learned from the COVID-19 pandemic.
“This is the first time a clinical trial has evaluated treatments for sepsis in real time, tailored to the biological profile of each patient, whether a child or an adult. PALETTE is a major innovation in the fight against the global scourge of sepsis,” says Prof. Djillali Annane.
1,200 to 2,000 patients, a major impact on public health
Supported in particular by the France 2030 program and the Ministry of Health through the National Hospital Clinical Research Program (National PHRC), PALETTE plans to enroll between 1,200 and 2,000 patients (including children) across more than 40 hospitals in France, prior to an international rollout, including in sub-Saharan Africa and South America. The first patient enrollments, particularly at centers within the CRICS-TRIGGERSEP and RENARCI networks—which hold F-CRIN accreditation—are expected in the second quarter of 2026.
One goal: to reduce the burden of sepsis
- For every patient, to increase the chances of a healthy life.
- For society, reduce the overall cost of treating sepsis and its consequences—fewer hospitalizations, less loss of independence, and a faster return to work and school.
- For science, to open new avenues in the understanding of infectious diseases.
By combining cutting-edge science, advanced digital systems, and international collaboration, PALETTE is realizing the vision of personalized sepsis medicine that is more effective, safer, and more equitable.
Did you know?
A “Bayesian” trial is particularly well-suited for analyzing data acquired sequentially, as it is collected. It provides decision-making tools based on initial results during the trial, allowing researchers to recommend discontinuing an ineffective strategy or reinforcing one that is working. This spares patients from treatments that prove ineffective and optimizes resources.
A center of excellence for care, research, and training on sepsis in children and adults that brings together 60 research teams in the fields of chemistry, physics, mathematics, engineering, biology, medicine, the social sciences and humanities, and economics, representing 275 researchers (including 117 female researchers and 41 early-career researchers) and 94 clinicians (including 44 female clinicians). The IHU SEPSIS has a threefold scientific mission. First, gaining a better understanding of the interactions between the host and pathogens that cause the progression from an uncomplicated infection to sepsis will enable the identification of signatures characterizing the trajectory of each individual with an infection (endotype) and their response to a given treatment (treatable trait). The establishment of a prospective cohort and the PALETTE platform trial, with methodological support from the clinical research unit at Saint Louis Hospital (Paris), provide a major foundation for characterizing these individual sepsis profiles. Furthermore, the identification of individual patient trajectories and the availability of rapid diagnostic tools and real-time modeling will enable the management of sepsis through precision medicine. This is the second objective: to develop personalized medicine using innovative small molecules such as nanomedicines, biotherapies (monoclonal antibodies and vaccines targeting pathogens and the immune system), and strategies that modulate the microbiome.
As Europe’s leading university hospital system (CHU), the AP-HP and its 38 hospitals are organized into six university hospital groups (AP-HP. Centre – Université Paris Cité; AP-HP. Sorbonne University; AP-HP. Nord – Université Paris Cité; AP-HP. Université Paris-Saclay; AP-HP. Henri-Mondor University Hospitals; and AP-HP. Paris Seine-Saint-Denis University Hospitals) and are structured around five universities in the Île-de-France region. Closely linked to major research organizations, the AP-HP comprises eight world-class university hospital institutes (ICM, ICAN, IMAGINE, FOReSIGHT, SEPSIS, lnovAND, reConnect, THEMA) and France’s largest health data repository (EDS). As a major player in applied research and innovation in healthcare, the AP-HP holds a portfolio of 810 active patents; its clinician-researchers author more than 11,000 scientific publications each year; and nearly 4,400 research projects are currently underway, across all funding sources. In 2020, the AP-HP was awarded the Institut Carnot label, which recognizes the quality of collaborative research: Carnot@AP-HP offers industry partners solutions in applied and clinical research in the healthcare field. In 2015, the AP-HP also established the AP-HP Foundation, which works directly with healthcare providers to support the organization of care, hospital staff, and research within the AP-HP. http://www.aphp.fr
Designated a “network of excellence” by F-CRIN in 2013, CRICS-TRIGGERSEP is a European network comprising 48 centers in France and Belgium. The network specializes in research on sepsis, a condition for which there were an estimated 48.9 million cases worldwide in 2019. Its goal is to better understand and improve the management of this disease. It comprises four working groups organized to optimize the expertise of each professional involved in this research, coordinated by Prof. F. Meziani and Prof. S. Ehrmann. The network has conducted 185 industrial and academic clinical studies, enrolling 5,237 patients in 2022. CRICS-TRIGGERSEP also contributes to high-quality scientific publications, including in *The Lancet*, *JAMA*, and *The New England Journal of Medicine*. In 2021, CRICS-TRIGGERSEP was involved in 66 publications related to COVID-19 and 32 publications on other topics. More information: https://www.crics-triggersep.org/
RENARCI (National Network for Clinical Research in Infectious Diseases) is a French national network dedicated to clinical research on severe bacterial infections and antibiotic resistance. Accredited by F-CRIN in 2025, it brings together more than 90 hospitals across France, including the overseas departments and territories. Coordinated by Professors David LEBEAUX (AP-HP Saint Louis-Lariboisière) and Xavier DUVAL (AP-HP Bichat Claude Bernard), RENARCI brings together infectious disease specialists, microbiologists, methodologists, and clinicians around multicenter projects—whether academic or industrial. The network aims to enhance the quality, visibility, and coordination of infectious disease research in France by adhering to high standards (ISO 9001 certification, expert governance, access to ECRIN). It has already enabled the enrollment of nearly 10,000 patients in various clinical trials. RENARCI plays a key role in the fight against antibiotic resistance and serves as a strategic driver for translational research in infectious diseases. For more information: https://www.infectiologie.com/fr/renarci.html
Established in 2012, F-CRIN (French Clinical Research Infrastructure Network) is a national platform dedicated to advancing clinical research in France. It is led by Inserm in partnership with hospitals, healthcare companies, and universities, and supported by the National Research Agency and the Ministry of Health. Its mission is to bring together clinical research stakeholders to strengthen the competitiveness and international appeal of French research, develop professionals’ expertise by pooling know-how, resources, and capabilities, and thereby accelerate the adoption of new practices and the development of new therapeutic solutions. “Uniting to Excel and Innovate” is F-CRIN’s ambition and motto. Today, F-CRIN is based on a federative model structured around 28 components: 26 thematic research and clinical investigation networks; a multi-service platform available to sponsors and investigators to support their trials; and a national coordination unit—the infrastructure’s headquarters—located in Toulouse. With more than 2,000 professionals pooling their expertise and resources, F-CRIN also serves as the French interface for the European clinical research network ECRIN, promoting the participation of French teams and centers in multinational clinical trials. For more information: https://www.fcrin.org
Press Contact: EVE'VOTREDIRCOM - 06 62 46 84 82 - servicepresse@votredircom.fr
