Saint Lo

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

Small Bowel Obstruction (SBO) often leads to emergency department visits and is usually diagnosed using an abdominal CT scan. Although CT scans help guide treatment decisions such as surgery or medical management, they have drawbacks including radiation exposure, higher costs, and longer emergency department stays. Researchers are evaluating the use of Point of Care Ultrasound (POCUS) combined with a clinical assessment called Gestalt probability to safely rule out SBO in patients with low or moderate risk, potentially reducing the need for CT scans. In this diagnostic multicenter study, trained emergency physicians perform POCUS on patients presenting with suspected SBO who have been assessed as having low or moderate Gestalt clinical probability. The ultrasound looks for signs of SBO in nine abdominal zones using a curvilinear probe. After POCUS, all patients undergo a CT scan, which serves as the gold standard for confirming SBO. The study aims to assess the ability of POCUS to exclude SBO in this patient group, with participation lasting 28 days including follow-up. Participants are involved during their emergency department visit with POCUS and CT imaging, followed by a phone call at 28 days. Researchers collect information on POCUS findings, duration, difficulty, and investigator details, while CT results are interpreted independently. The main outcome measures include the accuracy of POCUS to rule out SBO in patients with low or moderate Gestalt probability, aiming to improve patient care by reducing unnecessary CT scans, radiation exposure, costs, and radiologist workload.

Researchers are evaluating the effect of early sitting out of bed in an arm-chair position on the functional recovery of patients in intensive care who are on mechanical ventilation. The study focuses on patients with ICU-acquired weakness and aims to determine if this early mobilization technique improves functional and muscular recovery compared to a conservative strategy of sitting in bed. The research hypothesis is that early armchair positioning enhances functional recovery. Participants will be placed in a chair once awake with a Richmond Agitation-Sedation Scale (RASS) score between -1 and +1 for more than 12 hours. They will be seated daily for at least 30 minutes until discharge from intensive care or day 28, whichever comes first, unless there are temporary contraindications. If patients cannot communicate their wish to stop, their tolerance will be checked, and the chair session will not exceed 4 hours. During the study, researchers will assess participants' functional levels at discharge from intensive care or day 28, whichever occurs first. Patients will be monitored throughout their stay, and adherence to the intervention will be tracked. The total participation duration varies depending on the length of stay in intensive care, with functional recovery as the primary outcome measure.

Researchers are investigating the interactions between pregnancy and multiple sclerosis (MS), including related disorders such as neuromyelitis optica (NMO) and myelin oligodendrocyte glycoprotein (MOG)-antibody related disorders. This national prospective study aims to better understand how pregnancy impacts MS and associated conditions, focusing on questions about disease-modifying drugs (DMDs), breastfeeding, locoregional analgesia, and the short- and long-term effects on both mother and child. The study is nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort and includes patients across various MS-related diagnoses without age limits. Participants will not receive any experimental treatment but will be observed throughout pregnancy and up to one year after delivery. Their children will be followed until six years of age. The study collects data on pregnancy-related factors, use or discontinuation of DMDs, breastfeeding practices, and analgesia methods during delivery. Neurologists and researchers will gather information on the course of MS and related disorders before, during, and after pregnancy. During the study, participants will be monitored for treatment-related adverse events during pregnancy and the postpartum period, with assessments continuing for up to two years. Data collected will include clinical evaluations and long-term follow-up of both mothers and children. This comprehensive observation aims to provide clearer answers about the safety and impact of therapies and pregnancy-related factors on MS and related neurological conditions over time.

Researchers are evaluating immunotherapy treatments, such as anti-PD-1, PD-L1, or CTLA-4 inhibitors, in patients with various metastatic cancers that have shown response after 6 months of standard immunotherapy. This phase III randomized trial aims to compare the standard immunotherapy administration schedule with a reduced dose intensity schedule, given every three months, to see if the less frequent dosing can prevent disease progression just as effectively. The study is motivated by the need to find an optimal immunotherapy duration that balances treatment effectiveness, toxicity, patient quality of life, and cost. Participants will be randomized to continue either the standard immunotherapy schedule or switch to receiving the same immunotherapy drug every three months after an initial 6-month period of standard treatment. Treatment will continue until disease progression, unacceptable side effects, death, or a decision to stop treatment by the patient or investigator. This approach is based on evidence suggesting that immunotherapy drugs have long-lasting effects beyond their serum half-life and that less frequent dosing might maintain treatment effectiveness. Throughout the study, patients will undergo regular assessments including radiological imaging to determine disease response and progression, using RECIST or PERCIST criteria. The primary outcome measured is progression-free survival from randomization up to three years. Safety, toxicity, and patient quality of life will also be monitored. Participants must comply with scheduled visits and examinations, and the entire study duration includes treatment and follow-up periods to evaluate long-term outcomes.

Researchers are investigating treatments for advanced metastatic adenocarcinoma of the stomach and gastro-esophageal junction, a serious cancer with low survival rates. Current treatments include chemotherapy combinations and immunotherapy, which have improved outcomes for some patients. However, when cancer progresses after these therapies, options are limited, and new approaches are needed to extend survival and maintain quality of life. This international Phase III trial (FRUQUITAS) tests whether adding fruquintinib, an anti-angiogenic drug, to the oral chemotherapy drug trifluridine/tipiracil can improve survival for patients whose cancer has continued to grow despite prior treatments. The study compares two groups: one receiving trifluridine/tipiracil alone and the other receiving trifluridine/tipiracil combined with fruquintinib. Trifluridine/tipiracil is given orally twice daily on days 1 to 5 and days 8 to 12 of a 28-day cycle, repeated until disease progression or unacceptable side effects. Fruquintinib is taken orally once daily for 21 days of a 28-day cycle, also continued until progression or toxicity. This combination aims to block the tumor's blood supply while providing chemotherapy. The trial evaluates if this approach extends overall survival compared to chemotherapy alone. Participants will be adults with metastatic adenocarcinoma who have received two or three previous treatment lines. They will undergo regular assessments including tumor evaluations per RECIST criteria, blood tests to monitor organ function, and safety checks. Researchers will measure overall survival up to 18 months after starting treatment. The study involves ongoing monitoring for side effects and treatment tolerance, with participation lasting until disease progression, unacceptable toxicity, or withdrawal. Biological samples may also be collected for further research, and informed consent is required before enrollment.