Jossigny

Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the effects of early intravenous high-dose vitamin C combined with vitamin B1 in patients admitted to intensive care after an out-of-hospital cardiac arrest (OHCA) who develop post-cardiac arrest shock. This shock involves heart and blood circulation failure and can lead to multiple organ failure and early death in up to 35% of patients. The study is a phase II multicenter randomized controlled trial designed to assess if vitamin C and vitamin B1 can improve outcomes compared to standard care following OHCA. Participants are randomly assigned to one of two groups. The experimental group receives standard care plus intravenous high-dose vitamin C at 200 mg/kg per day, given as 50 mg/kg every 6 hours for 3 days, starting within one hour after randomization. They also receive intravenous thiamine (vitamin B1) 200 mg twice daily for 3 days. The control group receives standard care according to guidelines, with no high-dose vitamin C during the first 3 days. From day 4, standard vitamin C and thiamine supplementation at lower doses are allowed. During the 28-day participation, patients are monitored for recovery from the shock, including the need for blood pressure support medications (vasopressors). The primary outcome is the cumulative rate of weaning off vasopressors by day 3 after cardiac arrest. Researchers will also assess safety and recovery progress. The study plans to enroll 234 patients over 24 months, with follow-up lasting 28 days after enrollment.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition characterized by infection leading to organ failure and requiring mechanical ventilation. The study compares two fever management strategies: allowing fever to run its course versus controlling fever to maintain normal body temperature using external cooling. This trial follows a prior pilot study that suggested fever control might improve shock resolution and organ function, but its effect on mortality is still unclear. Participants will be randomly assigned to either respect fever or receive external cooling to maintain normothermia for 48 hours. The study uses an adaptive randomization method to balance groups and includes a subgroup of patients with acute respiratory distress syndrome (ARDS). Safety will be monitored closely by an independent committee, which may stop the trial if one strategy shows harm. An interim analysis will assess if fever control benefits patients with ARDS and guide continuation of the trial. Patients involved will be adults with septic shock, fever above 38.3°C, requiring invasive mechanical ventilation and sedation. Researchers will monitor mortality up to 60 days after randomization as the primary outcome. The study includes ongoing infection treatment and close safety monitoring. Participation involves observing the effects of fever management on survival and organ function over the study period.

Obesity affects a significant portion of the French population, and bariatric surgery is a common and effective treatment. This research compares two surgical methods for bariatric surgery: the traditional laparoscopic approach and a newer robotic approach using the Da Vinci system. The study aims to evaluate the cost-effectiveness of robot-assisted surgery compared to laparoscopy, particularly focusing on the balance between higher robotic costs and potential reductions in complications and improvements in quality of life one year after surgery. Participants will undergo either primary or revision bariatric surgery using one of two techniques: a robotic-assisted method with the Da Vinci X or Xi robot, or the conventional laparoscopic surgical approach. Both groups will be monitored and assessed for pain using a visual analog scale and for quality of life using the EQ-5D-5L and Impact of Weight on Quality of Life (IWQOL) questionnaires. Data on healthcare use will be collected through national health insurance records to support the health-economic evaluation. During the study, participants will be followed for one year after surgery to measure outcomes such as the incremental cost-effectiveness ratio, which looks at the cost per quality-adjusted life year gained. Researchers will evaluate post-operative complications, quality of life, and healthcare consumption. This trial includes adults aged 18 to 70 and will provide important information to guide patient care and public health policy regarding the use of robotic surgery in bariatric treatment.

Researchers are studying patients who have metastatic lung cancer and have survived for more than three years after their diagnosis without receiving cytotoxic chemotherapy. The focus is on understanding their clinical features, health status, quality of life, and socio-economic impacts, including the effects of cancer treatments, the occurrence of new diseases, and return to work. This observational study aims to better identify the needs of these long-term survivors to improve their management. Participants will complete several questionnaires, including the Hospital Anxiety and Depression Scale (HAD), the Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13), and the Aix-Marseille-University (AMU) questionnaire. These are designed to assess anxiety, depression, lung cancer symptoms, treatment side effects, and overall quality of life. Questionnaires are completed at the start of the study, at 6 and 12 months, and then yearly for up to 5 years. Participants will be followed during their regular medical consultations as per usual care at participating centers. Throughout the study, researchers will collect information on clinical characteristics, treatment details, health status, socio-demographic factors, and quality of life measures. Data will be gathered at baseline and during follow-up visits up to 5 years. This information will help assess the long-term impact of lung cancer and its treatments on patients who are living well beyond initial expectations.

This research aims to assess the pharmacokinetics, effectiveness, and safety of Hydroxycarbamide Paediatric dispersible tablets taken twice daily in children aged 9 months to 11 years who have Sickle Cell Disease. It is a phase II, open-label, non-randomised, multicenter study conducted nationally. The study focuses on understanding how the medicine is absorbed and processed in the body, along with monitoring its impact and safety in this young population. Participants will receive Hydroxycarbamide dispersible tablets, each containing 50 mg of the drug, given at half-strength doses twice daily. The dosing is adjusted based on the child's body weight. The treatment period lasts 12 months. During this time, children will attend clinic visits at screening, baseline, and then at 1, 3, 6, 9, and 12 months to receive the medication and undergo evaluations. Throughout the study, researchers will perform various tests including blood work to measure drug levels such as area under the curve (AUC), time to maximum concentration (Tmax), and maximum plasma concentration (Cmax) at multiple points after starting treatment. They will also monitor safety and efficacy through clinical assessments and laboratory values. The total duration for each participant in the study is one year, with regular follow-up visits to ensure adherence and collect data on health outcomes.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.