New Lambton

Researchers are evaluating various treatment strategies for Gram-negative bloodstream infections GN BSIs in a large, ongoing platform trial called BALANCE. This trial aims to improve treatment methods, patient outcomes, and reduce antimicrobial resistance. It builds on previous research and uses an adaptive design to answer critical questions about managing these serious infections in hospitalized patients. The trial studies different treatment approaches including antibiotic de-escalation, oral beta-lactam versus non-beta-lactam antibiotics, whether to replace or retain central vascular catheters, selecting cephalosporins or carbapenems for specific bacteria, and the use of routine follow-up blood cultures. Participants are randomly assigned to one of these treatment strategies within each domain, with ongoing adjustments based on interim analyses. The initial pilot study has completed, and all patients from that phase are included in the main trial. Participants will be monitored over 90 days for outcomes including death, reinfection, hospital readmission, and development of new antimicrobial resistance. Evaluations include laboratory tests, clinical assessments, and tracking of antibiotic use and patient health status. The trial uses a ranking scale combining these outcomes to determine the desirability of each treatment strategy. This adaptive platform design allows continuous learning and refinement of treatments to improve care for people with GN BSIs.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Mycobacterium abscessus MABS is a group of rapidly growing bacteria resistant to many drugs, causing lung infections that can lead to serious health problems, decreased lung function, and higher risk during lung transplants. The prevalence of MABS infections is increasing globally despite the relatively small number of affected people. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment FORMaT trial aims to identify the best treatment combinations to improve health outcomes while reducing side effects and treatment burden. It also seeks to develop biomarkers to guide treatment decisions and assess disease severity in patients with MABS pulmonary disease MABS-PD. The trial is an ongoing, adaptive study designed to test and improve combinations of therapies for both children and adults with MABS-PD. Participants receive various drug treatments including intravenous therapies such as amikacin, tigecycline, cefoxitin or imipenem combined with oral antibiotics like azithromycin, clarithromycin, and clofazimine. The study includes phases of intensive intravenous therapy followed by consolidation therapy with oral andor inhaled antibiotics. Treatments can be adjusted based on tolerance and microbiological response, with new therapies added or removed as evidence evolves. Participants are involved in screening, treatment, and follow-up visits extending up to 62 weeks. The study monitors microbiological clearance of infection alongside treatment tolerance. Assessments include lung function tests, chest CT scans, quality of life questionnaires, six-minute walk tests, and evaluation of treatment safety and resistance. Researchers also study health costs and reasons for early withdrawal. This comprehensive monitoring helps understand how treatments affect disease control, lung health, and patient well-being over time.

Researchers are evaluating the safety of a new insulin pump called the MiniMed NMX8 Automated Insulin Delivery AID System combined with the DS5Simplera continuous glucose monitoring sensor in children and adults living with Type 1 or Type 2 diabetes aged 7 to 85 years. The study aims to understand how well the pump works with this sensor and its safety profile across different ways of managing insulin boluses during meals. Participants will continue their current diabetes therapy while using the study devices. Participants will first wear the DS5Simplera sensor for up to 40 days while maintaining a meal and exercise log. Then, they will be randomly assigned to one of three groups for about 90 days one group will not bolus insulin for meals using the pump, another will bolus at every meal, and the third can bolus at will. After this period, participants may choose to join a Continued Access Period to keep using the NMX8 pump if they wish. During the study, participants will be monitored by recording their insulin use and maintaining logs of meals and exercise. The main outcomes measured include the percentage of time blood glucose levels stay within the target range 70-180 mgdL and the percentage of time spent in low blood sugar hypoglycemia over approximately 90 days. Participants must wear the system continuously and upload pump data via an app or computer. The study includes assessments like retinal eye exams and requires participants to use specific insulin types throughout the trial.

Researchers are investigating the best treatment approaches for infections in artificial hip and knee joints. This study compares different surgical methods, antibiotic choices, and durations of antibiotic treatment to determine which combinations lead to the best outcomes and cure rates at 12 months. The trial focuses on adults with infected artificial joints and aims to address the significant health and economic impacts of prosthetic joint infections. Participants may receive one of several surgical strategies cleaning the infected joint without removing the implant DAIR, or revision surgery where the infected implant is replaced either in a single operation or two stages. Antibiotic treatments are also compared, with some participants receiving standard antibiotics alone and others receiving additional rifampicin. The study further explores different lengths of antibiotic courses after revision surgery, including shorter and longer durations and extended prophylaxis after two-stage revisions. During the study, participants consent to have their medical and treatment information collected in a central database and registry. Researchers will assess health status, infection cure, joint function, quality of life, and antibiotic use at 100 days and 12 months after starting the study. Outcomes like reinfection, survival, and revision surgeries will be monitored up to two years. This study does not require extra tests or treatments beyond routine care and follows participants closely to evaluate treatment success and safety.