Belfort

Researchers are evaluating the use of Synolis VA 80160, a device containing hyaluronic acid and sorbitol, in adults with hip osteoarthritis. This study aims to assess the effectiveness and safety of this treatment over a 6-month period in patients experiencing symptoms related to this condition who have not responded well to standard pain relief treatments. The study is conducted independently across multiple centers. Participants will receive a single guided injection of Synolis VA 80160 directly into the affected hip joint. The study monitors changes in hip function and pain using the Oxford Hip Score at various points including 3 and 6 months after injection. Additional evaluations include patient self-assessments of symptom evolution and tracking whether participants require hip prosthesis placement within 6 months. During the study, participants will undergo assessments at baseline and follow-up visits where their hip function and symptoms are measured using standard questionnaires. The main outcome is the evolution of the Oxford Hip Score after 6 months. Researchers will also monitor safety and any need for hip replacement surgery. Participants will be involved for the full 6-month study duration, with data collected to understand both short-term and longer-term effects of the treatment.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

This research aims to describe HIV prevention practices in over 23 HIV sites across France, including overseas locations. It focuses on various aspects such as HIV screening, sexually transmitted infections STI screening, hepatitis screening, and the use of post-exposure prophylaxis PEP and pre-exposure prophylaxis PrEP. The study is observational and seeks to collect detailed information about HIV prevention measures in these diverse settings. Participants in this cohort study are observed based on their attendance for HIV prevention services including HIV, hepatitis, and STI screenings, as well as their use of PEP or PrEP. The study does not involve investigational treatments but follows participants over time to gather data on these prevention practices according to French national guidelines. During the study, researchers will track the number of people enrolled for HIV prevention over about one year, as well as proportions using PrEP and PEP and undergoing hepatitis and STI screenings. They will also monitor the incidence of sexually transmitted infections and hepatitis. Participants will provide informed consent and their progress will be observed without altering their usual care or treatment.

Researchers are studying ICU Acquired Weakness by evaluating whether early sitting out of bed in an arm-chair position improves functional recovery in patients who are ventilated in intensive care. This trial compares this early armchair positioning to a conservative strategy of sitting in bed, aiming to clarify if the armchair is essential for improving muscle and functional outcomes, as current guidelines do not strongly recommend this practice. Participants who have been awake with a certain alertness level RASS score between -1 and 1 for over 12 hours are randomly assigned to either daily chair sessions lasting at least 30 minutes or to no chair positioning. The chair sessions continue until ICU discharge or day 28, with careful monitoring of tolerance and a maximum session duration of 4 hours. The study follows patients through their ICU stay to assess recovery. During the study, researchers assess functional levels at ICU discharge or day 28, along with mobility scales, muscle strength scores, length of ICU and hospital stays, ventilator-free days, and mortality rates up to six months. Patients are monitored closely for safety and recovery progress throughout their ICU stay, with data collected to understand the impact of early armchair positioning on their health and function.

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.

Researchers are evaluating the timing of antibiotic therapy for patients suspected of having non-severe ventilator-associated pneumonia VAP in intensive care units. This study compares immediate antibiotic treatment started right after respiratory sampling with a conservative approach that waits for microbiological confirmation before beginning treatment. Delaying antibiotics may reduce unnecessary use and antibiotic resistance but might risk worse outcomes if infection is present. The study is a randomized controlled trial led by Nantes University Hospital to better understand these strategies in patients without severe symptoms like septic shock or severe respiratory distress. The trial has two groups the immediate strategy group receives empiric antibiotics within one hour after randomization based on clinical judgment and local protocols. If respiratory samples later test negative, antibiotics are stopped if positive, targeted therapy continues for seven days. The conservative strategy group does not start antibiotics until respiratory sample cultures or PCR results confirm infection. If confirmed, appropriate antibiotics are administered for seven days without waiting for susceptibility testing. Both approaches focus on managing suspected VAP to balance timely treatment and antibiotic stewardship. Participants will be monitored from day 0 to day 28, with assessments including mortality and mechanical ventilation status at day 28 as the main outcome. Additional evaluations cover organ failure scores, lung infection scores, duration of ventilation, use of supportive therapies, hospital and ICU stay lengths, infection incidence, antibiotic use, and cost-utility analysis up to day 90. The study involves informed consent, respiratory sampling within two hours of suspicion, and excludes patients with severe VAP or significant immunosuppression. This comprehensive follow-up aims to clarify the impact of antibiotic timing on patient outcomes and antibiotic resistance in ICU settings.

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.

In intensive care units, patients often need central venous catheters for care and safe medication delivery, but these devices can lead to infections. Most prevention focuses on how catheters are inserted and handled, but the length of time the catheter stays in place is a main source of infection. This research compares changing infusion sets every 7 days versus every 4 days to see if less frequent changes increase infection risk while considering impacts on nursing workload and costs. The study involves two groups one where infusion sets connected to the catheter are replaced every 7 days, and another where they are replaced every 4 days, the current standard recommendation. Each replacement involves disconnecting old sets and replacing them with new sterile ones. Both procedures are performed by qualified nurses during the patients ICU stay. Participants are adult ICU patients with a central venous catheter placed less than 72 hours ago and expected to remain for at least 7 days. Researchers will monitor infections related to the catheter from insertion until 48 hours after removal, along with bloodstream infections, catheter colonization, ICU length of stay, mortality, nursing time, and replacement costs. The study follows patients up to 90 days to collect these outcomes and assess the effects of the different replacement schedules.

Researchers are investigating the best noninvasive respiratory support method for patients in intensive care units ICUs who develop respiratory failure after planned removal of their breathing tube extubation. This condition affects about 20% of ICU patients, and many require reintubation, which is linked to high mortality rates. The study aims to compare whether alternating non-invasive ventilation NIV with high-flow nasal oxygen reduces death rates compared to high-flow nasal oxygen alone in these patients. The trial is a multicenter, randomized, controlled study where patients with post-extubation respiratory failure are assigned to one of two groups. One group receives continuous high-flow nasal oxygen treatment for 48 hours, while the other group receives NIV alternating with high-flow nasal oxygen during the same period. NIV involves pressure-support breathing with specific settings to help patients breathe, and the study ensures balance in patient groups based on carbon dioxide levels in the blood. Participants will be closely monitored with assessments including timing of death, reintubation events, days without ventilator use, length of ICU and hospital stay, and mortality at different time points up to 90 days. The main outcome measured is death rate 28 days after respiratory failure onset. The study includes clinical evaluations and blood gas tests to guide treatments and decisions. Participation duration includes the initial 48-hour treatment period and follow-up assessments extending to 90 days.

Researchers are evaluating the use of Interferon gamma to prevent secondary infections in patients with sustained immunosuppression acquired in the ICU. This phase 3 randomized trial aims to assess whether Interferon gamma reduces the number of secondary infection episodes at three months, lowers ICU mortality at day 90, shortens ICU and hospital stays, and promotes biological immune restoration by day 10. The study also examines cost-effectiveness and safety of Interferon gamma compared to a placebo. Participants will receive injections of Interferon gamma-1b or a placebo subcutaneously, preferably in the deltoid area or the front thigh. They will be given up to five injections between day 1 and day 9. The placebo consists of a saline solution with the same volume as the active drug. The treatment period lasts for up to nine days. During the trial, participants will be monitored daily until they leave the ICU, with follow-up visits at days 30, 60, and 90. Researchers will assess infection rates, causes of death, length of ICU and hospital stay, antibiotic and antifungal use, immune system recovery, healthcare costs, and any serious adverse reactions. The total participation duration extends to 90 days after treatment begins to evaluate outcomes and safety.