Umhlanga

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.

This research aims to collect clinical data on how effective, safe, and tolerable rezafungin combined with 7 days of co-trimoxazole is for treating Pneumocystis pneumonia (PCP) in adults living with HIV. The study is a Phase 2, open-label, randomized trial designed to expand knowledge about the clinical use of rezafungin in this population. Participants are adults diagnosed with PCP and HIV, and the trial compares the combination treatment to co-trimoxazole alone. The study includes a Screening period from Day -2 to Day -1, followed by a 21-day Treatment period and a Follow-up visit around Day 50. Participants are randomly assigned in a 1:1 ratio to receive either rezafungin with co-trimoxazole or co-trimoxazole alone. After treatment, all participants receive co-trimoxazole as secondary prophylaxis against PCP. For those allergic or intolerant to co-trimoxazole, alternative prophylaxis is provided based on local practices. Treatment groups are stratified by disease severity as mild or moderate-to-severe. Throughout the study, participants have their safety monitored from the first dose until the Follow-up visit on Day 50. Assessments include checking for adverse events, vital signs, lab tests like blood counts and chemistry panels, physical exams, and heart monitoring with ECGs. Researchers evaluate treatment response, rates of PCP relapse, and immune-related complications such as paradoxical IRIS. Prior and current medications are recorded, and the primary outcome is therapeutic failure by Day 8. The total study duration is approximately 52 days.