Tourcoing

Researchers are investigating treatments for adults with moderate to severe ulcerative colitis who have not responded well to steroids or other therapies. This Phase IV, randomized, open-label, multicenter trial aims to compare standard care with a treat-to-target approach using telemonitoring and patient education for those starting adalimumab (Humira4). The study will assess if home fecal calprotectin testing combined with e-monitoring and education improves patient outcomes by week 48. All participants will begin treatment with adalimumab at doses of 160 mg, then 80 mg, and 40 mg every other week until week 14, followed by 40 mg every other week until week 26. Based on patient and doctor preference, doses can be adjusted up to 80 mg every other week for two months and continued with azathioprine or methotrexate until week 38. Patients will also receive patient education sessions at weeks 0, 2, 14, 26, and 38, along with regular e-monitoring throughout the study. Participants will be followed for a total of 144 weeks across 20 sites in France. The main outcome is endoscopic remission at week 48, measured by an endoscopic Mayo score of 0. Additional assessments include clinical remission, steroid-free remission, healing rates, quality of life, patient satisfaction, safety, pharmacokinetics, hospitalizations, treatment adherence, and economic impact. Patients will report stool frequency, bleeding, and injection details via e-monitoring at multiple time points. This comprehensive monitoring aims to evaluate treatment effectiveness and patient engagement over time.

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

This research aims to evaluate the real-life effectiveness, safety, usage, tolerance, and satisfaction of four CE-marked isotonic and hypertonic seawater-based nasal sprays. It focuses on infants, children, adults, and pregnant or breastfeeding women who suffer from acute and chronic sinonasal conditions such as upper respiratory tract infections, COVID-19, bronchiolitis, allergic rhinitis, chronic rhinosinusitis, and post-surgery recovery. The study seeks to answer key questions on how well these nasal sprays work and how safe and satisfactory they are in everyday use. Participants will use one of four nasal sprays designed for different age groups and indications. The sprays are applied by spraying 1 to 3 seconds into each nostril multiple times daily, depending on the product and condition. Treatment for nasal symptoms ranges from 2 to 6 times a day, while hygiene and prevention uses are less frequent. The nasal sprays are used according to their intended purpose and population, including special instructions for babies, children, and adults. During the study, participants or their parents/caregivers will perform nasal washes following healthcare provider advice and complete online questionnaires about their symptoms and experience. Researchers will monitor nasal symptom improvement over 5 days for acute conditions and up to 14 days for chronic conditions. The study includes assessments of nasal symptom intensity, nasal breathing impairment, safety, and user satisfaction. Participants are expected to comply with study requirements for up to 3 months and have daily internet access for questionnaire completion.

This research focuses on patients without a functioning spleen, known as asplenic patients, which can result from surgical removal due to trauma, cancer, auto-immune diseases, or diagnostic purposes, as well as from treatments like radiotherapy or splenic artery embolization. These patients face increased risks of infections caused by encapsulated bacteria, cancer, and thromboembolic diseases. The study aims to assess the complications that occur in French asplenic patients and to introduce new diagnostic tools for better follow-up and management. The study observes different groups of asplenic patients including those who underwent splenectomy, splenic artery embolization, or radiotherapy. It seeks to understand how splenic function and immunity change over time in these patients, recognizing that infectious risks may vary among these groups. The research emphasizes the limitations of current tools that assess splenic function and aims to implement new methods to accurately evaluate residual splenic function. Participants will be followed over time to monitor infectious and non-infectious complications. The study includes assessments of complication risk factors over a period of three years. Researchers will collect data on patient health outcomes to better estimate the incidence of complications and improve understanding of these risks. This longitudinal follow-up helps in advancing care for asplenic patients through improved diagnostic and management strategies.

Researchers are investigating the best way to prevent stroke and systemic embolism in adults with atrial fibrillation (AF) who have previously experienced an intracerebral hemorrhage (ICH). While oral anticoagulants have proven effective in patients with AF, those with prior ICH were excluded from previous trials, leaving uncertainty about treatment options. This study focuses on patients with non-valvular AF and a history of spontaneous ICH to determine the safest and most effective preventive strategy. This clinical trial compares three treatment approaches over 24 months: taking the drug Apixaban (a direct oral anticoagulant) twice daily, undergoing left atrial appendage closure (LAAC) to prevent clots, or receiving usual care without anticoagulation. Participants are randomly assigned to one of these groups. The study uses an open-label design with masked outcome assessments to fairly evaluate the risk and benefits of each method. Participants will be monitored for major cardiovascular or brain bleeding events for up to two years after treatment begins. Evaluations include brain scans, clinical assessments, and follow-up visits to record any strokes, systemic embolisms, or bleeding complications. The main outcome measures combine these serious events to assess overall treatment safety and effectiveness. Results aim to guide doctors on managing AF in patients with prior ICH and improve care decisions in this challenging situation.

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.

The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.

Researchers are evaluating whether using fungal biomarkers can help doctors stop antifungal treatment earlier in critically ill patients suspected of invasive Candida infections. The study aims to compare this biomarker-based approach to the usual care strategy, assessing if early discontinuation can safely reduce unnecessary antifungal use without increasing mortality by day 28. This is a randomized controlled open-label study involving patients who need empirical antifungal therapy for the first time in the ICU. Participants are divided into two groups. The intervention group will have their antifungal treatment duration guided by blood tests measuring (1,3)-Beta-D-glucan and mannan levels at the start of treatment and on day 3, with recommendations to stop treatment early if biomarker results allow. The control group will receive routine care based on international guidelines, typically involving 14 days of treatment if no proven infection occurs and the patient improves, or shorter durations in other cases. During the study, researchers will monitor when antifungal treatment is stopped, particularly noting if treatment ends before day 7 after it begins. They will also track patient outcomes up to day 28 to ensure safety. Participants must provide informed consent and are expected to stay in the ICU for at least 6 days after starting treatment. The main outcome measured is the percentage of patients who stop antifungal therapy early according to the study protocols.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Charcot foot, a complication of diabetes involving progressive damage to bones, soft tissues, and tendons with joint dislocation in the ankle and foot, is not well understood by patients and caregivers. This condition often goes undiagnosed or is diagnosed late due to non-specific clinical signs. The study focuses on a prospective multicenter cohort in France to evaluate how quality of life changes over two years in patients with chronic, wound-free Charcot foot and to identify factors that predict worse outcomes in this population. Participants with chronic Charcot foot will complete several questionnaires including the SF-36, FAAM-F, PHQ-9, PHQ-2, and a simplified EPICES score. These tools aim to assess various aspects of health and quality of life. The study will track patient responses over two years to understand how their condition evolves without wounds and how it impacts their daily functioning and well-being. Throughout the study, patients will fill out these questionnaires at inclusion and follow-up visits. Researchers will analyze the results at the start, 12 months, and 24 months to measure changes in quality of life and foot and ankle functionality. This approach will help capture the progression of symptoms, any deformities, and the effect of comorbidities or diabetic complications. Participants will be monitored for two years to gain insight into long-term outcomes.