Essarts En Bocage

This research aims to evaluate antibiotic treatments for acute pyelonephritis AP in children aged 1 month to 3 years. It compares a shorter intravenous IV antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone andor amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are studying patients with completely removed non-small cell lung cancer NSCLC who have common mutations in the EGFR gene, specifically Del19 or L858R. The study aims to use broad-panel centralized next-generation sequencing NGS testing at the start to better understand molecular factors that predict outcomes and to investigate mechanisms of resistance to the drug osimertinib after treatment. This research focuses on patients with stage pIB to IIIA NSCLC who have undergone thorough preoperative assessments and quality surgical excision reviews. Participants will have plasma circulating tumor DNA ctDNA tested at various stages before surgery optional, 4 to 8 weeks after surgery, before starting adjuvant chemotherapy or osimertinib if given, every 6 months during follow-up, and at relapse if it occurs. Formalin-fixed paraffin-embedded FFPE tissue blocks from surgery and relapse optional will also be collected for molecular analyses. Treatment with osimertinib as adjuvant therapy is planned for up to 3 years, with chemotherapy given beforehand if needed. During the study, patients will be regularly followed every 3 to 6 months with standard care visits and molecular testing. Researchers will monitor the feasibility of the testing approach over 18 months and track the incidence and severity of any side effects related to osimertinib for about 3 years. This ongoing monitoring aims to better understand relapse mechanisms and improve treatment options in metastatic relapse. The total participation duration aligns with the follow-up and safety monitoring periods outlined.

Researchers are investigating whether adding cemiplimab, an immunotherapy drug, to neoadjuvant chemotherapy and sequential hypofractionated radiotherapy can improve survival outcomes for unfit or elderly patients with unresectable stage III non-small cell lung cancer NSCLC. The study compares the benefits of neoadjuvant chemotherapy alone versus chemotherapy combined with cemiplimab, followed by radiotherapy and maintenance immunotherapy. This phase II trial aims to assess both the effectiveness and tolerance of these treatments. Participants are randomly assigned to one of two groups one receiving neoadjuvant chemotherapy with carboplatin and paclitaxel alone, and the other receiving the same chemotherapy combined with cemiplimab. Both groups then undergo curative hypofractionated radiotherapy. Following radiotherapy, all participants receive maintenance immunotherapy with cemiplimab every three weeks for 12 months. The neoadjuvant chemotherapy cycles last for three cycles of four weeks each, and radiotherapy consists of 55 Gy over 20 fractions. During the trial, participants will be monitored through scheduled visits and laboratory tests to evaluate disease progression, response rates, survival, and treatment-related toxicity. Quality of life will be assessed using specific questionnaires for lung cancer. The primary outcome is progression-free survival over about 18 months, with secondary outcomes including overall survival and toxicity rates. Participants adherence and safety will be closely tracked throughout the study, which extends up to early 2032.

Researchers are investigating the role of rifampicin in treating prosthetic joint infections caused by Cutibacterium acnes, which is involved in nearly 40% of shoulder prosthetic joint infections and is a leading cause of late-onset infections after hip and knee prosthesis. The study focuses on the challenges posed by biofilm-associated bacteria in these infections, which have slower growth and may be less responsive to antibiotics. Rifampicin is known for its activity against biofilm-related staphylococcal infections and is being evaluated for its effect on C. acnes infections. Participants receive either amoxicillin or moxifloxacin alone or combined with rifampicin for 12 weeks as antibiotic treatment during surgical revision of infected knee, hip, or shoulder prostheses. The study uses a randomized, parallel design comparing the antibiotic backbone alone versus the combination with rifampicin. Treatment choice between amoxicillin and moxifloxacin is at the investigators discretion. Rifampicin use is being assessed for its impact on treatment outcomes. Throughout the study, participants are monitored for treatment failure and adverse events related to rifampicin up to 24 months after completing antibiotics. The main outcome is the rate of infection management failure 24 months post-treatment. Researchers also track probable failures and failures at 12 months. Safety assessments focus on adverse events during rifampicin therapy. The total study duration includes treatment and long-term follow-up to evaluate both effectiveness and safety.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

This research aims to evaluate the safety and effectiveness of EIK1001 combined with Pembrolizumab compared to placebo plus Pembrolizumab as a first treatment in patients with advanced melanoma. The study is a multicenter, randomized, double-blind, active comparator-controlled, adaptive Phase 23 trial including dose optimization and expansion parts. Participants must have advanced melanoma eligible for standard pembrolizumab therapy. Participants are assigned randomly to one of three groups placebo with Pembrolizumab, EIK1001 at dose 1 plus Pembrolizumab, or EIK1001 at dose 2 plus Pembrolizumab. EIK1001 is a dual agonist targeting Toll-like receptor 78, and Pembrolizumab is a PD-1 inhibitor. The study includes dose optimization and expansion phases to assess the treatments as first-line therapies. During the trial, participants will undergo regular assessments including imaging by CT or MRI to measure tumor response using RECIST 1.1 criteria. Safety is monitored through reports of adverse events and laboratory tests. The primary outcomes include progression-free survival and overall survival monitored up to 5 years, with additional evaluation of response duration and adverse events. Participation involves ongoing treatment and follow-up visits throughout the study period.

Researchers are evaluating two types of endovascular treatments for abdominal aortic aneurysms with short aortic necks measuring between 4 to 15 millimeters. The study compares the safety and performance of Endovascular Aneurysm Repair with EndoAnchor system ESAR using Endurant plus Heli-FX EndoAnchor devices against Fenestrated Endovascular Aneurysm Repair FEVAR using customizable grafts from Cook and Terumo. This randomized trial is sponsored by the Foundation for Cardiovascular Research and Education and focuses on patients who are not candidates for standard EVAR due to challenging anatomy. Participants are randomly assigned to receive either the ESAR treatment, which combines the Endurant II or Endurant IIs endograft with the Heli-FX EndoAnchor system, or the FEVAR treatment, which uses fenestrated grafts such as the Cook Zenith Fenestrated Graft or Terumo Fenestrated Anaconda Graft. Both treatments involve implanting devices to repair the aneurysm by reinforcing the weakened aortic wall and ensuring better sealing in difficult anatomy cases. Treatments are performed as procedures guided by imaging, and patients are monitored over time to assess the outcomes. During the study, participants undergo evaluations including imaging and clinical assessments to measure technical success within 12 months after the procedure and monitor safety by tracking major adverse events within 30 days. Additional follow-ups occur at 1, 12, 24, and 36 months to assess factors such as artery patency, endoleaks, secondary interventions, aneurysm rupture, device migration, and sac size changes. The study also reviews procedure details like contrast volume and fluoroscopy time. Participants are followed for safety and effectiveness for up to three years after treatment.

Researchers are evaluating novel RASON inhibitors alone or combined with standard treatments in adults with advanced RAS-mutated non-small cell lung cancer NSCLC and other solid tumors. This open-label Phase 1b2 platform study focuses on assessing safety, tolerability, drug behavior in the body, and early antitumor activity. The study includes patients with specific KRAS or RAS mutations and aims to determine the best dose and schedule for further study. The study has four subprotocols evaluating different combinations Subprotocol A tests RMC-6291 with or without RMC-6236 plus pembrolizumab and possibly chemotherapy for KRAS G12C-mutated tumors Subprotocol B uses RMC-6236 with pembrolizumab and possibly chemotherapy for RAS-mutated NSCLC Subprotocol C evaluates RMC-9805 with or without RMC-6236 plus other anticancer agents for RAS G12D-mutated NSCLC Subprotocol D studies RMC-9805 alone in previously treated RAS G12D-mutated NSCLC. Treatments involve oral tablets or intravenous infusions given at various schedules. Participants undergo screening to confirm eligibility, then receive assigned study treatments in dose exploration and expansion phases depending on subprotocol. Researchers monitor adverse effects up to five years and assess drug levels in the body during treatment. Tumor response and duration of response are also tracked long term. The total study duration may extend up to the study completion date in December 2028.

Researchers are evaluating the effectiveness of tarlatamab compared to standard chemotherapy treatments in patients with advanced, poorly differentiated neuroendocrine carcinomas NECs of the lung or gastroenteropancreatic system who have already received prior treatment. This phase 3 trial aims to explore how well tarlatamab works in this patient group, following evidence of its efficacy in small-cell lung cancer. The study is sponsored by the Intergroupe Francophone de Cancerologie Thoracique and focuses on patients with specific tumor characteristics, including DLL3 expression and tumor progression after platinum-based therapy. Participants will be randomly assigned to one of two groups one group will receive tarlatamab at a dose of 10 mg every two weeks, and the other will receive standard chemotherapy chosen by the investigator. Standard chemotherapy options may include immune checkpoint inhibitors, docetaxel, topotecan for lung tumors, or FOLFOX, FOLFIRI, or alkylating-based chemotherapy for digestive tumors. Treatments will be administered according to the schedule determined by the study protocol. During the study, participants will be monitored through various assessments including tumor response evaluations, safety and tolerability checks, and quality of life questionnaires using the EORTC QLQ-C30. The primary outcome is overall survival measured over about four years. Secondary outcomes include objective response rate, duration of response, disease control rate, and progression-free survival. Patients will be followed closely to assess treatment effects and side effects throughout the trial period, which begins after screening and informed consent.