Villeneuve Saint Georges

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

Researchers are evaluating the use of dual long-acting broadly neutralizing antibodies bNAbs combined with antiretroviral therapy ART in people diagnosed with primary HIV-1 infection. This phase II, placebo-controlled, randomized trial compares ART plus dual bNAbs to ART plus a placebo to study how these treatments affect HIV-1 control after stopping ART. The trial is conducted in French clinical centers and sponsored by ANRS, Emerging Infectious Diseases. Participants receive either ART with dual intravenous infusions of the bNAbs 3BNC117-LS and 10-1074-LS or ART with placebo infusions. Infusions start between days 7 and 10 after diagnosis, followed by at least 52 weeks of ART. After this period, participants undergo an analytical treatment interruption ATI where ART is stopped under close monitoring to observe viral rebound. Throughout the study, participants will have regular monitoring of HIV-1 RNA levels, CD4 counts, immune responses, and safety assessments up to 148 weeks. Researchers will track the proportion of participants maintaining low viral load 24 weeks after stopping ART, time to ART resumption, and any adverse events. The study duration varies per participant based on ART interruption timing and viral rebound, with detailed follow-up during and after the ATI period.

This research aims to evaluate the management of urinary tract infections UTIs in patients who visit the emergency department and are treated as outpatients. The study focuses on improving antibiotic use, particularly reducing the use of broad-spectrum antibiotics like fluoroquinolones, which can cause resistance and serious side effects. It is a prospective, multicenter, observational study conducted over six months to better understand antibiotic prescribing and adjustment practices. Participants include adults with suspected UTIs discharged from emergency care with or without initial antibiotic treatment. After 48 to 72 hours, a physician reassesses the antibiotic therapy based on urine culture and susceptibility test results. This reassessment may lead to stopping or narrowing the antibiotic treatment to more targeted options, aiming to optimize antibiotic use and reduce resistance. During the study, participants are followed up to monitor treatment changes, assess adverse effects, and evaluate patient satisfaction and knowledge about antibiotic resistance. Data collection includes urine cultures, antibiotic prescribing patterns, and questionnaires at 1 month after the emergency visit. The study helps understand how antibiotic therapy adjustments affect outpatient UTI management and aims to guide better clinical practices.

The Dataids cohort is a large, ongoing observational study following over 30,000 HIV-infected patients receiving care at more than 15 HIV centers across France. The study aims to monitor clinical practice, changes in the course of HIV infection and related co-infections or co-morbidities, and assess factors influencing the clinical, immunological, and virological outcomes of HIV. It also evaluates the effectiveness of antiretroviral therapy ART and outcomes related to hepatitis C virus HCV treatment. Patients enrolled in the cohort are followed during routine outpatient visits, regardless of their CD4 cell count, HIV viral load, or ART status. Data collected annually include demographic information, immunological and virological measures, serological tests for hepatitis B, hepatitis C, and syphilis, as well as laboratory, therapeutic, and clinical data. This long-term study has been enrolling patients since 2010 and continues to collect data prospectively. Participants provide data through their scheduled clinic visits, and researchers track outcomes such as the proportion of patients with undetectable HIV viral load, ART usage patterns, HCV treatment uptake and success, CD4 cell counts, and incidence of HIV-related events. The main outcome measured is the proportion of treated patients with HIV plasma viral load below 50 copiesmL, averaged over six months. The study extends through 2030, with ongoing annual monitoring and data collection as part of routine care.

The trial investigates the impact of different antibiotic treatments on the digestive tract colonization by extended-spectrum beta-lactamase-producing Enterobacteriaceae E-ESBL in children with febrile urinary tract infections UTIs. E-ESBL bacteria are a significant public health concern due to their resistance to many antibiotics. This research compares the emergence of E-ESBL strains in stools following treatment with either intravenous amikacin or other recommended antibiotics like ceftriaxone or cefixime in young children. Participants receive treatment for febrile UTIs with either amikacin given intravenously or with usual antibiotics such as intravenous or intramuscular ceftriaxone or oral cefixime. Before starting antibiotics, an anorectal swab is taken to check for E-ESBL colonization. A follow-up swab is performed three to four days after starting treatment to assess changes in bacterial presence. Children are monitored for the presence and type of E-ESBL bacteria in their stools four days after treatment begins. Researchers also track antibiotic resistance patterns, fever resolution, side effects related to antibiotic use, and the rate of UTI relapse over one and a half months. Participation involves stool sampling and clinical evaluations during the treatment period, with the study expected to complete by mid-2026.

This research aims to collect detailed information about hypoparathyroidism in France, a condition with few epidemiological studies worldwide and none specific to France. The study focuses on understanding the frequency of this condition, the medications used, and the complications it may cause, such as low calcium symptoms, calcifications in the brain and tissues, kidney stones, and kidney problems. Participants will not receive any treatment as part of this study since it is observational. The study gathers data from patients diagnosed with chronic hypoparathyroidism living in France to assess their medical history, current treatments, and any complications related to their condition. There is no intervention or drug administration involved. During the study, researchers will review participants biological data including calcium, urine calcium, parathormone, creatinine, phosphate, and magnesium levels at diagnosis and during treatment. They will also collect information about patient management and complications. This data collection will continue for about two years, helping to understand the conditions progression and treatment outcomes in the French population.