Etampes

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 adults hospitalized in the ICU with hospital-acquired sepsis caused by multidrug-resistant Gram-negative bacteria. It aims to compare different methods of giving beta-lactam antibiotics and the use of combination versus single antibiotic therapy. The study uses a 2x2 factorial design to evaluate these approaches for their impact on patient outcomes. Participants are randomly assigned to one of four groups that combine two antibiotic infusion strategies and two aminoglycoside dosing durations. The groups include continuous infusion of beta-lactam antibiotics with either a 5-day aminoglycoside infusion or a single dose, and intermittent beta-lactam infusion with the same aminoglycoside options. Treatment is administered according to the assigned group during the ICU stay. Throughout the study, researchers monitor patients for 30 days to assess mortality rates and kidney-related adverse events. Participants undergo bacteriological sampling before treatment and are followed with several clinical and microbiological evaluations, including infection status and organ function. The study tracks outcomes such as survival, kidney events, infection resolution, and length of ICU and hospital stay, with follow-up extending up to 180 days after inclusion.

Major depressive disorder is a leading cause of disability worldwide, with current treatments like antidepressants often taking 2 to 6 weeks to show effects. This delay can lead to hospitalization for severe major depressive episodes MDE. Researchers are evaluating the early effects of intravenous ketamine, alongside standard venlafaxine treatment, in patients hospitalized with severe unipolar depression to potentially improve early treatment response and reduce risks such as suicidal ideation and long hospital stays. Participants in this study will receive either three doses of intravenous ketamine or placebo on days 1, 4, and 7, in addition to their usual venlafaxine treatment. The study compares ketamine to placebo as an add-on therapy to venlafaxine during this early treatment phase. The study is randomized and quadruple-blinded to assess the efficacy and safety of ketamine in this setting. During the study, participants will be closely monitored for depressive symptoms using tools like the Hamilton Depression Rating Scale HDRS, Beck Depression Inventory BDI, and Clinical Global Impression CGI at multiple time points up to 42 days. Safety parameters such as blood pressure, heart rate, respiratory rate, and side effects like nausea and dissociation will also be tracked. Additional assessments include hospitalization duration, suicidal ideation, anxiolytic use, biomarkers, and PET imaging in a subset of patients. The total follow-up period extends to 42 days after treatment initiation.

Researchers are evaluating how an early and extended rehabilitation program that combines personalized nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this tailored rehabilitation program to usual care, aiming to support recovery from critical illness. The study is a multicenter randomized controlled trial led by Nantes University Hospital. Participants will be assigned randomly to either the rehabilitation group or the usual care group. Those in the rehabilitation group receive a customized program starting early in the ICU and continuing through the post-ICU ward and at home for 12 weeks. This program involves goal-directed nutrition and physical activities adjusted to each patients progress, with support from dieticians, physiotherapists, and physical activity instructors. The usual care group receives standard nutritional support and physiotherapy based on local practices from day 0 to day 180. Throughout the study, participants will undergo various assessments including walking distance measured by a 6-minute walk test at 6 months, muscle strength, muscle mass, physical activity levels, calorie and protein intake, body weight, mortality rates, blood glucose monitoring, and quality of life surveys. These evaluations occur at multiple time points during and after hospitalization, up to one year. The study includes careful monitoring of mechanical ventilation duration, infections, hospital stay lengths, and other safety outcomes. Participant involvement spans from ICU admission through long-term follow-up.

People with mental disorders tend to smoke more than the general population, which contributes to a significant reduction in their life expectancy by 10 to 20 years, mainly due to heart and lung diseases such as bronchial cancers. Despite this, smoking cessation efforts tailored for psychiatric patients are limited, as smoking is often overlooked or accepted in mental health care settings. This study aims to assess a smoking cessation program called Tabapsy designed with input from mental health users, professionals, and general practitioners, focusing on adult patients receiving outpatient psychiatric care. The Tabapsy intervention includes a campaign promoting smoking cessation within psychiatric medical psychological centers CMPs and a series of supportive activities. These activities involve an initial information meeting to boost motivation, an assessment workshop to evaluate nicotine dependence and create personalized quitting plans, five thematic workshops covering nicotine replacement, emotional management, weight control, physical activity, and manual tasks, and peer support groups for shared experiences. A dedicated facilitator will lead these sessions, supported by an online resource website. The study compares the intervention against usual care in a national cluster-randomized trial involving psychiatric sectors. Participants who smoke regularly and consent will complete questionnaires via a web app at the start, 3 months, and 6 months, with additional surveys for those in the intervention group. The questionnaires cover smoking habits, dependence, motivation, cessation aid use, mental and physical well-being, and knowledge about tobacco. The main outcome is smoking cessation lasting at least 7 days at 3 months. Secondary outcomes include cost-effectiveness, implementation, quit attempts, and satisfaction. A total of 6,250 participants will be enrolled over 12 months across 22 sectors.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating a new anti-regurgitation infant formula to see how well it reduces regurgitation episodes and improves digestive tolerance in infants with gastroesophageal reflux. This is a randomized, controlled, double-blind trial comparing the new formula to a standard thickened formula. The study is sponsored by United Pharmaceuticals and focuses on infants between 2 weeks and 4 months old. The study includes two groups one receiving the new formula thickened with fibers and the other receiving a formula thickened with locust bean gum. The trial lasts for 1 month and 2 days, starting with a 2-day pre-selection period followed by a 30-day follow-up. Participants can optionally continue for an additional 2 months of follow-up from day 30 to day 90. During the study, infants will be monitored for the frequency and severity of regurgitations, digestive symptoms like diarrhea and constipation, feeding behaviors, sleep quality, and growth measurements including weight, length, head circumference, and BMI. Parents and investigators satisfaction will also be recorded. These assessments occur at days 14, 30, and 90. The primary outcome is the frequency of regurgitation at day 14. All study visits and evaluations are conducted under careful monitoring to track safety and treatment effects.

Researchers are evaluating the French version of the Prediction of Alcohol Withdrawal Severity Scale PAWSS in adults with Alcohol Use Disorders AUD. This observational study aims to validate whether the French version has similar psychometric properties to the original English scale. The PAWSS helps predict the risk of complicated alcohol withdrawal, such as seizures or delirium tremens, which can occur during hospital stays when alcohol consumption stops abruptly. Participants are hospitalized adults aged 18 to 60 with moderate to severe AUD who understand French and are affiliated with the social security system. Participants are followed for three days during their hospital stay. On the first day, they provide consent and clinical data, complete surveys including DSM-5 AUD criteria, AUDIT, the French PAWSS twice by two investigators, and the CIWA-AR scale every 8 hours. On days two and three, the CIWA-AR scale is administered every 8 hours to monitor withdrawal symptoms. During the study, participants complete several questionnaires and scales to assess alcohol withdrawal severity and risk. Researchers measure the psychometric qualities of the French PAWSS and its ability to predict complicated withdrawal, determine the optimal cutoff score, and evaluate benzodiazepine use. The study includes close monitoring of withdrawal symptoms with regular assessments over three days. Participation involves hospital stay assessments and completion of validated scales to support safer withdrawal management.