Chartres

Researchers are collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools FFR and OCT, peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closurecompression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.

Researchers are evaluating different antimicrobial therapies for infections caused by difficult-to-treat Pseudomonas aeruginosa, a type of bacteria resistant to many common antibiotics. This study focuses on comparing new beta-lactambeta-lactamase inhibitor combinations, cefiderocol, and older treatments like aminoglycosides and colistin to understand their effectiveness in real-life settings for patients facing these challenging infections. The study is a prospective, multicenter cohort involving patients who require intravenous antibiotic treatment for their P. aeruginosa infections. Participating patients will receive one of the available antimicrobial options, and their bacterial samples will be analyzed centrally to assess susceptibility and resistance mechanisms. The study collects clinical data throughout treatment and monitors outcomes such as cure rates, resistance development, adverse events, and mortality. Participants will be followed until hospital discharge and up to 28 days after treatment completion. Researchers will track clinical cures, microbiological eradication, adverse events, emergence of resistance, and acquisition of other multidrug-resistant bacteria. Data collection includes electronic case reports and laboratory testing on bacterial isolates. The total participation duration varies according to hospital stay and follow-up schedules, with rigorous monitoring of safety and treatment outcomes.

This research focuses on patients without a functioning spleen, a condition known as asplenia, which can be congenital or acquired through surgery, radiotherapy, or splenic artery embolization. The study aims to assess the risk factors for complications such as infections, cancer, and blood clots in French patients with asplenia. Researchers want to better understand how the immune system and splenic function change over time in these patients. Participants include adults aged 18 and older who have asplenia due to splenectomy, embolization, or radiotherapy. The study is observational and follows patients prospectively over time to monitor complications. It seeks to implement new diagnostic tools to evaluate residual splenic function and improve patient management. The study distinguishes three groups based on the cause of asplenia to examine differences in infection risks. During the study, participants will be followed longitudinally for at least three years to assess complication risk factors. Researchers will use new and existing tools to monitor splenic function and immune status. The main measurement is the incidence of infectious and non-infectious complications. This long-term follow-up aims to provide detailed data on risks faced by asplenic patients to guide better care.

Researchers are evaluating the best hypnotic drug to balance good intubation quality and stable blood pressure during rapid sequence induction RSI in the operating room. This Phase 3 randomized study compares the effects of propofol, ketamine, and a combination of both drugs for patients needing RSI under general anesthesia. The main goal is to see which option allows successful intubation on the first attempt without causing major drops in blood pressure. Participants will receive one of three treatments after pre-oxygenation a direct intravenous injection of propofol at 2 mgkg, ketamine at 2 mgkg, or a combination of ketamine 1 mgkg followed by propofol 1 mgkg. The combination treatment does not require dilution. These treatments are given consecutively in the operating theater and monitored closely during the procedure. During the study, participants will be assessed for successful intubation and blood pressure stability within 10 minutes after hypnotic injection. Researchers will also monitor heart rate, oxygen levels, fluid and medication use, and any complications such as pulmonary aspiration. Tolerance to the drugs will be followed during the recovery room stay and up to seven days after surgery. The study runs from April 2025 to April 2027 and includes detailed safety and effectiveness measurements.

Researchers are evaluating the EkiYou V2 Digital Therapy in adults with diabetes who use multiple daily insulin injections as part of a basal-bolus insulin regimen. This multicenter randomized controlled trial aims to compare the performance of this digital therapy with conventional insulin management methods and assess user satisfaction and quality of life. The study is sponsored by DiappyMed and follows 154 adults over a 6-month period. Participants will be randomly assigned to either receive the EkiYou V2 device at the start or continue their standard basal-bolus insulin care for three months before switching to the device for the remaining three months. The EkiYou V2 is a mobile application that supports insulin dose estimation, including basal insulin dose, insulin-to-carb ratios, and correction factors. It uses a large food database, accounts for meals, physical activity, and glucose levels, and connects to continuous glucose monitoring CGM devices. During the 6-month study, participants will attend three visits and complete electronic questionnaires to report their quality of life and satisfaction with the application. Researchers will monitor glucose control through CGM data, measuring time spent in the target glucose range and other glucose-related outcomes. Safety events and adverse effects related to the device will also be tracked throughout the trial.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

Researchers are investigating the best length of prednisone treatment for patients with granulomatosis with polyangiitis GPA and microscopic polyangiitis MPA, serious autoimmune diseases that can relapse and cause damage despite current treatments. Rituximab is commonly used to maintain remission, but the ideal duration for prednisone therapy remains unclear. This trial is the first prospective study to compare longer versus shorter prednisone use as an add-on to remission maintenance in these conditions. Participants will receive either prednisone 5 mg per day or a placebo for 12 months, with dosing beginning on Day 1. Prednisone dosage will be tapered by 1 mg per week until complete withdrawal after 12 months. The study is randomized, double-blind, and placebo-controlled, evaluating the impact of extended prednisone use alongside rituximab maintenance therapy. During the 30-month study period, participants will be monitored for relapse-free survival, defined by a disease activity score BVAS greater than zero. Researchers will also assess serious adverse events, glucocorticoid-related complications like fractures and weight gain, vasculitis relapse rates, prednisone use, bone density, disease damage, functional disability, quality of life, and healthcare resource use. Assessments include clinical evaluations and standardized questionnaires to track disease status and treatment effects over time.

In intensive care units, patients often need central venous catheters for care and safe medication delivery, but these devices can lead to infections. Most prevention focuses on how catheters are inserted and handled, but the length of time the catheter stays in place is a main source of infection. This research compares changing infusion sets every 7 days versus every 4 days to see if less frequent changes increase infection risk while considering impacts on nursing workload and costs. The study involves two groups one where infusion sets connected to the catheter are replaced every 7 days, and another where they are replaced every 4 days, the current standard recommendation. Each replacement involves disconnecting old sets and replacing them with new sterile ones. Both procedures are performed by qualified nurses during the patients ICU stay. Participants are adult ICU patients with a central venous catheter placed less than 72 hours ago and expected to remain for at least 7 days. Researchers will monitor infections related to the catheter from insertion until 48 hours after removal, along with bloodstream infections, catheter colonization, ICU length of stay, mortality, nursing time, and replacement costs. The study follows patients up to 90 days to collect these outcomes and assess the effects of the different replacement schedules.

Chronic kidney disease CKD is a significant global health concern, with hypertension being the leading risk factor for death, cardiovascular problems, and progression to end-stage kidney disease in these patients. Lowering blood pressure is known to reduce these risks, but the best second-line treatment after initial therapy with ACE inhibitors or angiotensin receptor blockers ARBs is unclear. This study aims to compare a diuretic-based blood pressure lowering approach to usual care in patients with moderate to severe CKD and uncontrolled hypertension. Participants are assigned to one of two groups one group receives blood pressure management guided by a diuretic-based algorithm, while the other group follows the usual care provided by their clinicians, which may include pharmacological or non-pharmacological therapies. The study is a randomized, open-label, phase 3 trial using a parallel design. Treatment adjustments are made according to the assigned strategy, and the study will continue for up to 36 months to observe outcomes. During the study, participants will be monitored for kidney function decline, cardiovascular events, all-cause mortality, and blood pressure control. Researchers will assess changes in kidney filtration rate, proteinuria, diuretic use, and quality of life over time. Regular evaluations will include blood pressure measurements and other clinical assessments to track the effectiveness of the treatment strategies. The total participation time can last up to three years, with ongoing monitoring of health outcomes throughout this period.

Researchers are investigating whether patients treated with antiplatelet inhibitors who have minor head injury traumas and meet no other NICE criteria truly need a CT scan to rule out cerebral haemorrhage. This observational, prospective, multicenter study focuses on patients with head injuries seen in emergency rooms, where current protocols recommend CT scans based on NICE criteria, which include antiplatelet inhibitor treatment. The study aims to clarify if antiplatelet treatment alone justifies a CT scan or if it can be safely excluded as an indication. Patients in the study will first undergo a clinical exam at the emergency room. If they meet the criteria, they will then receive a CT scan to detect any cerebral haemorrhage. The study follows the routine emergency protocol for antiplatelet inhibitor-treated patients with minor head injury and other NICE criteria. After the initial assessment and imaging, patients will be monitored for one month through follow-up calls to check for any complications such as cerebral haemorrhage, neurosurgery, hospitalization, or death. During their participation, patients will have a Glasgow coma score evaluation and a CT scan within one day of the injury. The primary outcome measured is the presence of cerebral haemorrhage on the CT scan. Secondary outcomes include rates of neurosurgery, death, and hospitalization events within one month. Follow-up calls at one month will collect information on morbidity and mortality, allowing researchers to assess the reliability of the NICE criteria in this patient group and the safety of potentially avoiding CT scans in certain cases.