Perigueux

Researchers are creating a national, prospective cohort to study children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The goal is to collect detailed data on patients treated in pediatric nephrology centers across France, Reunion Island, Mayotte, and eventually other French overseas territories. This structured follow-up aims to better understand the disease's characteristics and provide a foundation for future clinical trials. The study involves enrolling pediatric patients diagnosed with INS and systematically collecting clinical, biological, psychological, and social data. Biological samples such as blood, urine, hair, and nails will be gathered at disease onset before immunosuppressive treatment begins. Data will be recorded through medical records from hospital visits and consultations, supplemented by annual telephone interviews for patients without active disease. Quality of life, treatment adherence, and aesthetic impact questionnaires will also be collected and integrated into a secure database. Participants will be followed over at least two years, with data collected regularly by clinical research staff. This includes medical validation of clinical information, annual telephone follow-ups, and questionnaire assessments. The study's primary outcome is the number and characteristics of included cases over two years. This ongoing monitoring will support future nested studies and improve understanding of pediatric INS outcomes and management.

This research aims to evaluate the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis. The study is conducted in France and focuses on understanding how this treatment performs outside of controlled clinical trial settings. Participants in this observational study will be newly starting deucravacitinib as prescribed by their treating clinician. There are no additional study treatments or placebo groups, as the study observes the outcomes of the treatment during routine clinical care. During the study, researchers will assess clinical outcomes including the Physician's Global Assessment (PGA) and the Dermatology Life Quality Index (DLQI) at baseline and at months 4, 12, 18 (optional), and 24. They will also monitor how long participants remain on deucravacitinib treatment, up to 24 months. These evaluations help to measure both the effectiveness and impact on quality of life for participants with plaque psoriasis.

Researchers are evaluating the clinical effectiveness and safety of two antibiotic treatments, amoxicillin alone versus amoxicillin/clavulanate, for community-acquired pneumonia (CAP) in patients aged 65 years or older who are hospitalized in non-intensive care unit (ICU) wards. The study addresses an important public health concern about reducing inappropriate antibiotic use, especially since broad-spectrum antibiotics may cause side effects and contribute to antibiotic resistance. This Phase 3 trial aims to fill the evidence gap on the best antibiotic choice for older adults with CAP by directly comparing these two treatments. Participants will be randomly assigned to receive either intravenous or oral amoxicillin or amoxicillin/clavulanate for five days. The amoxicillin group will take 500 mg capsules three times daily or 1 g intravenously every eight hours. The amoxicillin/clavulanate group will receive two tablets of 500 mg/62.5 mg orally every eight hours or 1 g/200 mg intravenously every eight hours. Both regimens are approved for respiratory infections, and the study will assess clinical outcomes at 30 days after starting treatment to determine if amoxicillin alone is not worse than the combination therapy. During the study, participants will be monitored for clinical signs and safety outcomes up to 30 days after inclusion. Researchers will evaluate the patients' clinical response to treatment and any side effects. The trial involves multiple centers and includes follow-up calls or contacts to ensure adherence and collect necessary data. This study will provide important information to guide future treatment guidelines for older adults hospitalized with CAP.

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.

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

Researchers are evaluating the immune response to two pneumococcal vaccination strategies in adults treated for lymphoma, including diffuse large B cell lymphoma and follicular lymphoma. The study compares the combined injection of conjugated 13-valent pneumococcal vaccine (PCV13) followed by polysaccharide 23-valent vaccine (PPV23) with a newer recommendation of a single injection of PREVENAR20. This research aims to understand how well these vaccinations stimulate immunity in patients whose immune systems may be weakened by chemotherapy, as these patients have a higher risk of pneumococcal infections. The study also seeks to identify factors that predict poor vaccine response and assess vaccine safety in this population. Participants are divided into two groups: cohort A receives the PCV13 injection followed two months later by the PPV23 vaccine, representing the previous standard approach; cohort B receives a single PREVENAR20 injection following updated guidelines. Immunological responses will be tracked at multiple time points: day 0, 4 weeks post PCV13, and at 4 weeks, 3-6 months, and 9-12 months after PPV23 for cohort A; and at day 0, 4 weeks, 3 months, 5-8 months, and 11-14 months after PREVENAR20 for cohort B. Throughout the study, participants will have blood tests to measure specific pneumococcal antibodies and immune activity. Researchers will monitor antibody levels and opsonophagocytic activity to gauge immune response. The study will also collect demographic and treatment data to help understand response predictors. Safety and tolerance of the vaccines will be observed carefully during follow-up visits. The main outcome is the proportion of patients showing an immune response four weeks after completing the combined vaccine strategy or three months after PREVENAR20 injection.

This research focuses on men with benign prostatic hyperplasia (BPH), a condition causing urinary symptoms due to prostate enlargement. It evaluates whether a modified surgical technique that preserves ejaculation can provide similar relief of urinary symptoms as the conventional surgery, potentially improving quality of life by maintaining sexual function. The study is a multicenter, single-blinded, randomized clinical trial comparing two surgical methods for BPH treatment. Participants will undergo either partial trans urethral resection of the prostate, which preserves the prostatic apex to maintain ejaculation, or conventional complete endoscopic resection of the prostate. Both procedures aim to relieve urinary symptoms caused by BPH. The study compares the functional outcomes of these two surgeries, including urinary flow, ejaculatory function, sexual life quality, and surgery-related complications. During the study, men will be evaluated before surgery and followed for at least 6 months afterward. Assessments include the International Prostatic Symptom Score (IPSS) to measure urinary symptoms, ejaculatory function, sexual life quality, urinary flow rates, and monitoring for any complications or need for retreatment. The primary outcome is the IPSS score at 6 months post-surgery, helping to determine if the ejaculation-preserving technique is as effective as the conventional surgery for improving symptoms.

Researchers are evaluating treatments for men aged 45 to 75 with favorable intermediate risk prostate cancer. This study compares focal High-Intensity Focused Ultrasound (F-HIFU) with radical prostatectomy (RP) to see which treatment is more cost-effective and provides better quality of life over 24 months. The trial is multicenter and randomized, initially with equal groups but later adjusted to a 2:1 ratio favoring F-HIFU, with follow-up extending to 48 months using health system data to monitor costs, mortality, and cancer control. Participants receive either F-HIFU using the Focal-One4 machine under local or general anesthesia, targeting specific prostate areas, or undergo radical prostatectomy performed by open, laparoscopic, or robot-assisted surgery under general anesthesia. Treatments follow standard procedures at each center, with randomization done up to 2 months before the procedure. During the study, participants will be monitored through medical records and health system data without extra visits. Researchers will assess the cost-effectiveness of treatments based on quality-adjusted life years (QALYs) at 24 months. Safety, cancer control, and mortality will also be tracked up to 48 months. The total participation time includes treatment and long-term follow-up using existing health data sources.

Researchers are evaluating treatments for patients with uncomplicated catheter-related bloodstream infections (CR-BSIs) caused by Staphylococcus aureus. This Phase 3 trial compares a single intravenous dose of dalbavancin to the standard 14-day antibiotic therapy recommended by national guidelines. Staphylococcus aureus CR-BSIs are common in patients with catheters used for chemotherapy or nutrition and can lead to serious health issues, longer hospital stays, and high healthcare costs. The study aims to show that dalbavancin is not less effective than the standard treatment by day 30 after therapy. The study involves two treatment groups: one receives a single intravenous dose of 1500 mg dalbavancin, or 1000 mg for those with severe kidney impairment, after catheter removal. The other group receives the standard antibiotic therapy for 14 days according to national guidelines, which may include an early switch to oral antibiotics after at least 7 days of intravenous treatment. The start of treatment is considered the day of randomization or inclusion in the study. Participants will be monitored through follow-up visits on day 14, day 30, and day 90 to evaluate cure rates, mortality, blood culture results, quality of life, hospital stay duration, and any side effects. Researchers will also assess healthcare costs and safety outcomes. This comprehensive follow-up lasts up to 90 days to gather information on treatment effectiveness and patient well-being.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with or without low-dose cyclophosphamide (CPA), in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This Phase 2b, randomized, open-label study aims to compare these treatments in patients who have previously received at least two lines of systemic therapy but whose disease has progressed. Participants will be randomly assigned to one of two groups: one group will receive DPX-Survivac, pembrolizumab, and intermittent low-dose CPA; the other group will receive DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two subcutaneous injections three weeks apart followed by up to twelve smaller doses every eight weeks. Pembrolizumab is administered by intravenous infusion every three weeks. For those in the CPA group, oral CPA is taken twice daily in a cycle of seven days on and seven days off, continuing throughout treatment. During the study, participants will be monitored for treatment response over approximately 24 months, focusing on the objective response rate in each group. Evaluations include tumor biopsies before and during treatment, laboratory tests, and disease assessments. Safety will be closely observed, and participants must have a life expectancy greater than three months to join. The study plans to enroll up to 102 subjects, with regular follow-up to track treatment effects and side effects.