Etampes

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.

Researchers are evaluating the effects of different antibiotic infusion strategies in patients hospitalized in intensive care units with hospital-acquired sepsis caused by multidrug-resistant Gram-negative bacteria. This Phase 4 trial uses a 2x2 factorial design to compare continuous versus intermittent infusion of pivotal beta-lactam antibiotics and combination therapy with aminoglycosides versus monotherapy. The main goal is to assess 30-day mortality and major adverse kidney events in these patients. Participants are randomly assigned to one of four treatment groups: continuous infusion of beta-lactam antibiotics combined with a 5-day aminoglycoside infusion, intermittent infusion of beta-lactam antibiotics with a 5-day aminoglycoside infusion, continuous infusion of beta-lactam antibiotics with at most one dose of aminoglycoside, or intermittent infusion of beta-lactam antibiotics with at most one dose of aminoglycoside. Randomization also accounts for the type of beta-lactam administered. Treatments are delivered according to these infusion schedules during the ICU stay. During the study, patients will be monitored for vital outcomes including survival at 30 days after sepsis diagnosis and kidney function events such as the need for renal replacement therapy or persistent kidney dysfunction. Researchers will collect relevant clinical data and bacteriological samples before starting treatment. The study focuses on patients expected to stay in the ICU for more than three days and will observe their progress closely during the 30-day period following sepsis onset.

Major depressive disorder is a leading cause of disability worldwide, with commonly used antidepressant medications often having limited effectiveness and a delayed onset of 2 to 6 weeks. This delay can necessitate hospitalization, especially for those experiencing severe major depressive episodes (MDE). Researchers are investigating whether adding intravenous ketamine to venlafaxine treatment can improve early symptom relief in hospitalized patients with severe unipolar depression. Previous studies have shown ketamine's benefits in treatment-resistant depression and its potential to increase synaptic density in the brain. In this Phase 3 study, participants are randomly assigned to receive either intravenous ketamine or a placebo alongside venlafaxine over one week, with infusions occurring on Days 1, 4, and 7. Both groups continue venlafaxine treatment while receiving their assigned intravenous infusions. This design aims to assess the early effects of ketamine compared to placebo when used with venlafaxine in treating severe depressive episodes. Participants will be closely monitored through clinical assessments of depressive symptoms at the start of the study and after one week. Researchers will measure changes in depressive symptomatology to evaluate early treatment efficacy. Safety monitoring and follow-up will also be conducted throughout the study period. Overall participation lasts at least one week during which treatment and assessments are performed to determine the early impact of the interventions.

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.

People with mental disorders tend to smoke more than the general population, which partly causes significant health differences and shorter life expectancy by 10 to 25 years. This gap is mainly due to heart and lung diseases, including bronchial cancers. Despite their motivation to quit, smoking is often overlooked or tolerated in psychiatric care, making quitting harder due to stronger withdrawal symptoms. This research evaluates a new intervention called "Tabapsy," designed with input from patients, mental health professionals, and general practitioners to support smoking cessation in adults receiving outpatient psychiatric care. The Tabapsy intervention includes a campaign to promote quitting smoking and a structured support program with multiple components: a general information meeting to boost motivation, an assessment workshop to personalize cessation plans, five thematic workshops covering treatments, emotional management, weight control, physical activity, and manual activities, plus peer support groups to encourage mutual help. A dedicated facilitator runs the program in psychiatric medical psychological centers (CMPs), supplemented by a website with resources. The study compares this intervention to usual care practices regarding smoking cessation in a cluster-randomized controlled trial involving psychiatric sectors in France. Participants are regular smokers aged 18 or older who receive outpatient psychiatric care at participating centers. They will complete questionnaires online at the start, and again at 3 and 6 months, covering smoking habits, nicotine dependence, motivation, use of quitting aids, mental and physical well-being, and knowledge about smoking. The main outcome is short-term smoking cessation lasting at least 7 days at 3 months. Secondary goals include assessing cost-effectiveness and how well the intervention is implemented. A total of 6,250 participants will be enrolled over 12 months across 22 sectors.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are studying the effectiveness and tolerance of a new anti-regurgitation infant formula designed to reduce regurgitation episodes in infants with gastroesophageal reflux. This randomized, controlled, double-blind trial compares the new formula thickened with fibers to a formula thickened with locust bean gum. The goal is to assess how well the new formula reduces regurgitation frequency and its effects on digestive tolerance. Participants will exclusively feed their infants either the experimental formula or the comparator formula during the study. The study lasts for 1 month and 2 days, beginning with a 2-day pre-selection period, followed by a 30-day follow-up period. There is an optional additional 2-month follow-up phase to further monitor the infants. During the study, parents and researchers will track the frequency of regurgitation on day 14 as the primary outcome. Other assessments include monitoring digestive tolerance and overall infant health. Parents provide informed consent and participate in feeding and observation activities throughout the study duration, which may last up to 3 months if the optional follow-up is added.

This research aims to validate the French version of the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) in patients with Alcohol Use Disorders (AUD). AUD affects a significant portion of hospitalized patients, and abrupt cessation of alcohol during hospital stays can lead to alcohol withdrawal syndrome, which may range from mild symptoms to severe complications like seizures and delirium tremens. The PAWSS scale, originally developed and validated in English, helps predict the risk of complicated alcohol withdrawal to guide appropriate treatment and reduce risks. This study evaluates if the French PAWSS has similar psychometric properties as the English version in a population of hospitalized AUD patients. Participants will be hospitalized adults aged 18 to 60 years with moderate to severe AUD, who understand French and are affiliated with the French social security system. Over three days, patients will undergo assessments including the French PAWSS scale, DSM-5 AUD criteria, AUDIT, and CIWA-AR scales. On day 1, consent and clinical data are collected, and the PAWSS and CIWA-AR scales are administered twice and every 8 hours respectively. Days 2 and 3 involve CIWA-AR assessments every 8 hours to monitor withdrawal symptoms. This observational study does not involve any treatment interventions. During the study, participants will complete several surveys and scales to assess alcohol withdrawal risk and severity. Researchers will monitor psychometric qualities of the French PAWSS over 3 days to confirm its reliability and predictive value. The main outcome is the evaluation of the French PAWSS scale's psychometric properties compared to the English version. Safety and withdrawal progression are tracked with regular CIWA-AR assessments. The total study duration for each participant is three days during hospitalization.