Jossigny

This research aims to evaluate antibiotic treatments for acute pyelonephritis AP in children aged 1 month to 3 years. It compares a shorter intravenous IV antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone andor amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are investigating the use of high-dose intravenous vitamin C combined with thiamine vitamin B1 to manage post-cardiac arrest shock in patients admitted to intensive care units after out-of-hospital cardiac arrest. This condition often leads to cardiac and circulatory failure, causing multi-organ failure and early death in a significant portion of patients. The study is a phase II, multicenter, randomized controlled trial comparing standard care with the addition of high-dose vitamin C and thiamine to assess potential benefits on shock recovery and neurological outcomes. Participants are randomly assigned to one of two groups the control group receiving standard post-cardiac arrest care according to international guidelines, and the experimental group receiving standard care plus high-dose intravenous vitamin C at 50 mgkg every 6 hours for 3 days, starting within an hour after randomization, along with intravenous thiamine 200 mg twice daily for 3 days. From day 4 onwards, standard vitamin C supplementation up to 1000 mg daily and thiamine are allowed in both groups. During the 28-day participation period, patients will be closely monitored for recovery from shock, neurological function, and organ failure. Assessments include measuring the time to stop vasopressors by day 3, survival rates related to shock by day 7, neurological status at day 28, maximum vasopressor doses within 3 days, changes in organ failure scores, and arterial lactate levels. Safety and effectiveness data will be collected throughout to evaluate the impact of the vitamin C and thiamine treatment alongside standard care.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition caused by infection leading to organ failure and requiring mechanical ventilation. This study compares two fever management strategies allowing fever to run its course or controlling fever to maintain normal body temperature using external cooling. The trial aims to determine which approach better improves survival by looking at death rates 60 days after treatment starts. Participants will be randomly assigned to one of two groups one group will receive external cooling to keep their body temperature normal for 48 hours, while the other group will have their fever left untreated without antipyretic therapy. The study uses a special randomization method to ensure groups are comparable and includes a subgroup of patients with lung injury. Safety is closely monitored by an independent committee that can stop the study if needed. During the trial, patients will be monitored for various health outcomes including organ function, need for ventilator support, kidney therapy, and blood pressure support over specific time points. Researchers will also track side effects such as shivering, seizures, low body temperature, heart rhythm problems, infections, and development of lung or kidney complications. The total study duration includes follow-up to assess these outcomes and safety events up to 60 days after randomization.

Obesity is a serious condition affecting 17% of the French population, with bariatric and metabolic surgery recognized as the primary treatment. This trial evaluates whether using the Da Vinci robot for bariatric surgery offers a cost-effective advantage over conventional laparoscopic surgery by potentially reducing complications and improving quality of life. The study is a randomized, controlled, single-blind, multicenter trial involving 482 patients undergoing primary or revisional bariatric surgery. Participants are randomly assigned to receive either robot-assisted bariatric surgery using the Da Vinci X or Xi system or conventional laparoscopic surgery. The study collects data on healthcare consumption linked to the surgeries by matching patient information with the French National Health Insurance database. Quality of life is assessed with the EQ-5D-5L questionnaire. Both surgical approaches follow the recommendations of the French National Authority for Health regarding eligibility based on body mass index and comorbidities. During the study, participants will undergo assessments of surgical complications, pain levels, readmission and reintervention rates, quality of life through questionnaires, duration of surgery, hospital stay, weight loss, and treatment changes up to 12 months after surgery. Data on costs and health outcomes will be analyzed to calculate the incremental cost-effectiveness ratio at one year. The total study duration extends to July 2028, with ongoing monitoring of health and economic outcomes relevant to bariatric surgery.

Researchers are studying patients who have lived for three years or more after being diagnosed with metastatic lung cancer and who are no longer receiving cytotoxic chemotherapy. The study aims to understand these patients clinical characteristics, health status, socioeconomic impacts, quality of life, and their ability to return to work. This observational research focuses on both non-small cell lung cancer NSCLC and small cell lung cancer SCLC. Participants will be observed over time without receiving experimental treatments. They will complete several questionnaires related to quality of life, anxiety, and depression at the start of the study, then at 6 and 12 months, and annually for up to five years. Their health and treatment history, including any ongoing therapies like immunotherapy or targeted therapy, will be recorded throughout the study. During the study, participants will continue their usual medical care and attend regular consultations as needed. Researchers will collect data through questionnaires and health evaluations to measure clinical characteristics, health status, socioeconomic factors, and psychological well-being. The main outcomes include baseline clinical data and repeated assessments over five years to better understand long-term survivorship after metastatic lung cancer diagnosis.

Researchers are evaluating the pharmacokinetics, efficacy, and safety of Hydroxycarbamide pediatric dispersible tablets given twice daily in children aged 9 months to 11 years with Sickle Cell Disease. This phase II, national, multicenter, non-randomized, open-label study aims to understand how the drug is processed in the body and its effects over a 12-month period. Participants will take Hydroxycarbamide twice daily for 12 months. They will attend clinic visits at screening, baseline, and at 1, 3, 6, 9, and 12 months during the study. The drug dosage is adjusted based on body weight and administered as half-strength dispersible tablets. Childrens involvement includes regular clinic visits for blood tests, monitoring of drug levels, and assessments of blood parameters and Sickle Cell Disease events. Acceptability of the treatment will be evaluated by both children and their parents using scales. Compliance will be tracked by pharmacy accountability of the medication units. Safety and adverse events will be closely monitored throughout the study duration.