Belfort

Researchers are evaluating the efficacy and safety of Synolis VA 80/160 in treating symptoms of hip osteoarthritis over a period of 6 months. This multicenter, independent study focuses on adults with hip osteoarthritis confirmed by specific clinical and radiographic criteria. The study aims to assess patient outcomes using measures like the Oxford Hip Score to track improvements in hip pain and function. Participants will receive Synolis VA 80/160, a device containing hyaluronic acid 80 mg and sorbitol 160 mg, designed to be injected into the hip joint. The study includes patients who have experienced inadequate relief from standard pain treatments and have not had prior injections in the target hip within the last 6 months. The treatment and follow-up periods extend over 6 months to monitor effects and safety. Throughout the study, participants will be monitored for changes in hip pain and function using the Oxford Hip Score at 6 months. Assessments include clinical evaluations, radiographic imaging, and safety observations. Participants’ adherence and responses will be tracked to evaluate the treatment's impact on hip osteoarthritis symptoms and overall patient well-being during the study period.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Dat'AIDS Prevention is a cohort study conducted across more than 23 HIV sites in France, including overseas locations. It aims to describe all aspects of HIV prevention such as HIV screening, screening for sexually transmitted infections (STIs) and hepatitis, as well as the use of post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). The study focuses on individuals seeking HIV prevention services to better understand prevention efforts in these settings. Participants include HIV-negative men and women aged 18 years and older attending for various services such as HIV screening, hepatitis screening, STI screening and treatment, exposure to blood, body fluids or sexual contact, and use of PEP or PrEP. Those who agree to participate provide signed consent to be included in the study. Throughout the study, researchers will track the number of patients enrolled for HIV prevention from the date of enrollment through to study completion, which lasts about one year on average. Participants will be monitored during this period to gather data on prevention practices and outcomes, supporting a comprehensive understanding of HIV prevention in France.

Researchers are evaluating the effect of early sitting out of bed in an arm-chair position on the functional recovery of patients in intensive care who are on mechanical ventilation. The study focuses on patients with ICU-acquired weakness and aims to determine if this early mobilization technique improves functional and muscular recovery compared to a conservative strategy of sitting in bed. The research hypothesis is that early armchair positioning enhances functional recovery. Participants will be placed in a chair once awake with a Richmond Agitation-Sedation Scale (RASS) score between -1 and +1 for more than 12 hours. They will be seated daily for at least 30 minutes until discharge from intensive care or day 28, whichever comes first, unless there are temporary contraindications. If patients cannot communicate their wish to stop, their tolerance will be checked, and the chair session will not exceed 4 hours. During the study, researchers will assess participants' functional levels at discharge from intensive care or day 28, whichever occurs first. Patients will be monitored throughout their stay, and adherence to the intervention will be tracked. The total participation duration varies depending on the length of stay in intensive care, with functional recovery as the primary outcome measure.

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.

Ventilator-associated pneumonia (VAP) is a common and serious infection in intensive care units, often leading to prolonged mechanical ventilation and excessive antibiotic use. This trial evaluates two strategies for starting antibiotic therapy in patients with suspected non-severe VAP: immediate antibiotic treatment after sampling versus waiting for microbiological confirmation before starting treatment. The study aims to balance the risks of unnecessary antibiotic exposure against the dangers of delaying therapy in infected patients, considering concerns about antibiotic resistance and patient outcomes. Participants are randomly assigned to one of two groups. The control group receives immediate empiric antibiotic therapy within one hour of randomization, based on clinical judgment and local protocols; treatment is stopped if respiratory samples are negative or continued for seven days if VAP is confirmed. The conservative strategy group waits for respiratory sample culture and/or PCR results before starting antibiotics; if results are negative, no antibiotics are given, and if positive, treatment is started promptly and continued for seven days without waiting for susceptibility testing. Throughout the study, participants are monitored for death or continued use of invasive mechanical ventilation up to 28 days. Researchers record the proportion of patients who die or remain on ventilation at 28 days as the primary outcome. The study involves patients who have been mechanically ventilated for more than 48 hours and meet specific clinical criteria for suspected VAP without signs of severe illness, with informed consent obtained from patients or their representatives.

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.

Patients in intensive care units often require a central venous catheter to deliver medications safely. These catheters, however, can sometimes cause infections, especially the longer they remain in place. Most prevention efforts focus on how the catheter is inserted and handled, but less attention is given to how long the catheter and its connected infusion sets stay in place, which is a key factor in infection risk. This research compares two schedules for changing the infusion sets connected to central venous catheters. One group will have their infusion sets replaced every 7 days, while the other group will follow the usual practice of replacing them every 4 days. During each replacement, all tubing and connectors will be disconnected and swapped with new sterile equipment to reduce contamination risk. Participants will be monitored from catheter insertion until 48 hours after removal, or up to 90 days in the ICU, to track infection rates related to the catheters. Researchers will collect data on infection complications and assess whether the less frequent 7-day replacement increases infection risk compared to the standard 4-day schedule. This study also considers the impacts on nursing workload and medical resource use.

Researchers are evaluating the effect of Interferon-gamma, a standardized immunotherapy, on preventing secondary infections in patients with sustained immunosuppression acquired in the ICU. This phase 3 randomized trial aims to determine if Interferon-gamma reduces the incidence of secondary infection episodes at three months, lowers ICU mortality up to day 90, shortens ICU and hospital stays, promotes biological immune restoration by day 10, and is cost-effective compared to a placebo. Participants will receive either Interferon Gamma 1-b injections or placebo injections for up to 5 times between day 1 and day 9. The study medication is given under the same conditions for both groups. After treatment, participants are monitored daily until ICU discharge and then followed up at days 30, 60, and 90 to assess outcomes and safety. During the study, patients will undergo regular evaluations including daily monitoring in the ICU and follow-up visits after discharge. Researchers will track secondary infections, mortality, length of ICU and hospital stay, immune function restoration, and economic outcomes. The main outcome measure is the occurrence of secondary infection episodes by day 90. Safety and adherence are closely observed throughout the participation period.

Researchers are conducting the Dataids cohort, a long-term prospective study involving over 30,000 HIV-infected patients receiving care at more than 15 HIV centers across France. The study aims to monitor clinical practices, track changes in the course of HIV and related infections, and evaluate factors influencing the clinical, immunological, and virological progression of HIV. It also focuses on assessing antiretroviral therapy (ART) effectiveness and monitoring hepatitis C virus (HCV) treatment outcomes. Participants in the study include HIV-1 infected patients regardless of their CD4 cell count or ART status. Data collection occurs as part of routine outpatient clinic visits, with annual gathering of demographic, immunological, virological, serological, laboratory, therapeutic, and clinical information. The cohort has been ongoing since 2010, reflecting real-world clinical care and treatment patterns in France. Throughout the study, researchers track participants’ HIV plasma viral load to evaluate treatment success, specifically measuring the proportion of patients with viral loads below 50 copies/mL over an average of six months from enrollment. Data on co-infections such as hepatitis B and C, as well as syphilis, are also collected. This observational design allows ongoing surveillance of HIV infection trends and treatment effectiveness, supporting improved care quality for HIV patients in France.