Epagny Metz Tessy

Researchers are evaluating the safety and tolerance of elritercept, a recombinant fusion protein, in adults with anemia linked to lower-risk myelodysplastic syndromes (MDS). The study aims to understand how elritercept affects red blood cell production and to monitor participants for any worsening of MDS during treatment. This is a Phase 2, open-label study focused on patients with very low, low, or intermediate risk MDS. Participants receive elritercept through subcutaneous injections at different dose levels to assess safety and effects. The study includes multiple parts, with initial treatment cycles followed by an extension phase for those who complete the first part without dose-limiting toxicities and may benefit from continued treatment. The study also includes several cohorts based on specific MDS characteristics and transfusion needs. During the study, participants undergo regular evaluations including blood tests, bone marrow assessments, and monitoring for adverse events. Researchers will track the number of treatment-emergent and serious adverse events for up to 11.2 years. Participants are closely monitored for how well they tolerate elritercept and its impact on anemia and red blood cell production throughout the study duration.

Researchers are evaluating the PRESTAGE educational program in elderly cancer patients who are receiving oral anticancer treatments. The study focuses on patients aged 70 years and older and aims to improve treatment adherence, a key issue in this population due to factors like multiple medications and cognitive challenges. This trial is a prospective, interventional, open-label, multicenter, randomized controlled study designed to assess the acceptability and impact of the PRESTAGE program, which is the first of its kind targeting elderly cancer patients. The PRESTAGE program involves a multidisciplinary team including nurses, physicians, pharmacists, psychologists, physiologists, and social workers. It offers six educational workshops tailored to the patient's needs, covering understanding of disease and treatment, drug management, nutrition, psychological support, and physical well-being. After an initial individual educational diagnosis, patients receive between one and six workshops, followed by a final interview to assess skills and satisfaction. Participants will be monitored for adherence to their oral anticancer therapy using a MicroElectronic Monitoring System after four months. The study also evaluates quality of life and changes in patient behaviors. Patients must be able to complete questionnaires and protocol evaluations, and they will be followed regularly during the study period. The total participation involves adherence monitoring and assessments over at least four months after the intervention.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Severe chest trauma often involves multiple rib fractures and causes significant pain that can hinder breathing and secretion clearance, potentially leading to lung complications and respiratory distress. Managing pain early is crucial, especially for patients who breathe spontaneously or require mechanical ventilation, as pain can prolong the need for ventilatory support. This trial evaluates whether starting continuous erector spinae plane (ESP) block analgesia early after severe chest trauma can reduce the days patients need invasive or non-invasive ventilation. Participants in the experimental group will receive a continuous ESP block within the first 6 hours after admission. This involves placing a catheter to deliver a steady infusion of the local anesthetic ropivacaine, with additional bolus doses every 6 hours. The catheter remains in place from the trauma bay to the intensive care unit for as long as possible, using a dedicated pump. If the catheter is accidentally removed or the block fails, adjustments are allowed, including possible switch to standard care. During the study, researchers will monitor respiratory support duration, assessing how many days participants are alive without needing ventilation over 30 days. Patients will be closely observed for safety and treatment effects throughout their stay in intensive or intermediate care. The trial aims to provide evidence on whether early continuous ESP block can improve respiratory outcomes and reduce ventilatory support after severe chest trauma.

Researchers are evaluating the effectiveness of cotrimoxazole compared to the best standard antibiotic treatment for ventilator-associated pneumonia (VAP) caused by Enterobacteriaceae in adult patients admitted to intensive care units (ICU). This is a multicenter, randomized, non-inferiority Phase 3 trial aiming to show that cotrimoxazole is not worse than standard care in terms of patient survival 28 days after treatment begins. Participants must have a confirmed diagnosis of VAP with bacteria susceptible to cotrimoxazole. Patients are randomly assigned to receive either cotrimoxazole or the best standard antibiotic therapy, which may include beta-lactam or fluoroquinolone antibiotics. Treatment lasts for seven days, starting with an initial appropriate empiric antibiotic therapy. The dosing and administration of antibiotics are tailored according to current ICU guidelines. The trial is open-label due to variable antibiotic regimens in the control group. During the study, patients are closely monitored daily until death, ICU discharge, or 28 days after inclusion. Assessments include vital status, antibiotic use, new infections, and Clostridium difficile infections. Clinical signs and chest X-rays are reviewed on day 7 to evaluate cure. Weekly screenings for multidrug-resistant bacteria are performed until ICU discharge. The vital status is also checked at day 90, with follow-up contact for patients discharged before this time. An independent committee reviews the clinical and radiological outcomes without knowing the treatment assignments.

Researchers are evaluating the effectiveness of early continuous intravenous infusion of hypertonic saline solution (HSS) in improving survival and daily life independence at six months for patients with traumatic brain injury (TBI) who are at high risk of intracranial hypertension. This Phase 3, single-blinded, multicenter, randomized controlled trial aims to assess neurological outcomes by comparing this treatment with standard care in TBI patients with severe brain injury. Participants in the study receive a continuous infusion of 20% hypertonic saline solution for 48 hours, which can be extended if intracranial hypertension persists. The treatment starts within the first 12 hours after intracranial pressure (ICP) monitoring is placed based on the attending physician's judgment. The study includes careful monitoring and evaluation during the treatment period. During the trial, patients undergo ICP monitoring and clinical assessments to evaluate neurological outcomes and survival. Researchers will measure the efficacy of the early continuous HSS infusion at both three and six months after treatment. Safety and long-term effects are also followed to determine the overall impact on patient recovery and independence in daily activities.

Researchers are evaluating a paramedical training program for nurses and nursing assistants aimed at improving care for elderly patients aged 75 years and older hospitalized in specialist wards. The study focuses on preventing hospital-related complications (iatrogenesis) and reducing the length of hospital stay, which tends to increase with age. This research is inspired by successful American programs that enhanced geriatric care by training nursing staff, and it aims to adapt these approaches to the French healthcare context. The intervention involves training nurses and nursing assistants using a model similar to hygiene correspondents, supported by Geriatric Mobile Teams (GMT). The GMTs coordinate and support this training to disseminate good geriatric practices systematically. This approach builds on previous programs that emphasized the role of nursing staff in reducing complications like hospital confusion among elderly patients. Participants will be monitored for the length of their hospital stay, calculated from admission to discharge, up to one month. The study will also assess the prevention of hospital-related complications through this training approach. Eligible patients will be tracked during their hospital stay, and researchers will use medical records to measure outcomes. The total participation duration corresponds to the patient’s hospital stay within the study period.

Large-cell neuroendocrine carcinomas (LCNECs) of the lung are rare and aggressive tumors included with small-cell lung cancers in a subgroup of high-grade pulmonary neuroendocrine tumors. Diagnosing LCNEC is challenging, and the prognosis for advanced cases is poor, with survival typically around 8 to 10 months. Researchers are evaluating the effectiveness of combining durvalumab with etoposide and platinum-based chemotherapy as a first-line treatment for advanced LCNEC, based on promising results from related lung and digestive cancer studies. Participants receive treatment with durvalumab combined with etoposide and either carboplatin or cisplatin. The treatment starts with an induction phase consisting of 4 cycles every 3 weeks for 12 weeks, followed by a maintenance phase with durvalumab every 4 weeks for up to 24 months. This open-label, multicenter phase II study uses an external control arm for comparison and aims to assess both efficacy and safety. Throughout the study, participants will undergo regular medical evaluations including imaging scans and laboratory tests to monitor disease progression and treatment effects. The primary outcome measured is the progression-free rate at 12 months. Safety and tolerability will also be monitored. Patients will be followed closely during treatment and maintenance phases, with scheduled visits every few weeks over a period extending up to two years.

Researchers are evaluating whether an early, personalized rehabilitation program that combines nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for adults who have been critically ill and required mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this extended rehabilitation approach to usual care given during and after ICU stay. The study includes patients starting invasive mechanical ventilation recently and aims to support recovery from critical illness through tailored interventions. Participants are assigned to either the rehabilitation group or the control group. The rehabilitation group receives a customized program beginning early in the ICU and continuing through the post-ICU hospital stay and then at home for a total of 12 weeks. This program uses goal-directed nutrition and physical activity adjusted over time by specialists including dieticians, physiotherapists, and physical-activity instructors. The control group receives the usual care available at each ICU from day 0 to day 180. Throughout the study, participants will be monitored to assess their recovery progress, with the primary outcome measuring the distance walked in 6 minutes at 6 months. Researchers will gather data on physical function and health improvements during and after the rehabilitation period. The study includes follow-up assessments up to 180 days to evaluate the long-term effects of the rehabilitation program compared to usual care.