Umhlanga

Researchers are evaluating the safety and effects of a medicine called fosmanogepix for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida yeast. This Phase 3 clinical trial compares fosmanogepix to the standard treatment using caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard treatment by a margin of 15%. The study includes adult patients diagnosed with these infections and is sponsored by Basilea Pharmaceutica. Participants are randomly assigned to one of two groups two-thirds receive fosmanogepix intravenously, with an option to switch to oral tablets, while one-third receive caspofungin intravenously followed by oral fluconazole. Matching placebos are given to maintain blinding. Treatments are given daily, first by IV infusion at the clinic and then orally either at the clinic or at home if discharged. Treatment duration can be up to six weeks, depending on infection clearance and symptom improvement. Participants will be monitored through multiple study visits, with assessments including survival status at 30 days, treatment success at the end of treatment, and follow-up evaluations six weeks after stopping treatment. Additional evaluations include clinical and mycological responses, blood cultures, safety monitoring such as adverse events, lab tests, neurological exams, ECGs, and drug concentration measurements. The total study duration for each participant may be approximately 12.5 weeks, considering treatment and follow-up periods.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

Researchers are evaluating the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus SLE who have previously completed treatment in one of two core SIRIUS-SLE studies. This Phase 3 extension study compares monthly or quarterly subcutaneous ianalumab to monthly placebo in participants who are positive for anti-nuclear antibodies ANA. The study aims to understand how ianalumab performs over an extended period in this patient group. Participants receive ianalumab either monthly or quarterly via subcutaneous injection, or a monthly placebo injection, throughout the extension study. Only those who completed the initial 60-week treatment period of the core studies without discontinuation are eligible. The study involves random assignment to one of the three groups and follows a quadruple-blind design to ensure unbiased results. During the trial, participants are monitored for treatment-emergent adverse events and serious adverse events up to approximately 91 months. Researchers also assess lupus disease activity, damage progression, corticosteroid use, and flare rates. Safety and tolerability are closely observed through regular evaluations, with the study lasting until April 2032, allowing for comprehensive long-term data collection.

This research aims to evaluate the effectiveness, safety, and tolerability of rezafungin combined with 7 days of co-trimoxazole compared to co-trimoxazole alone 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 definitive, presumptive, or clinically suspected PCP and living with HIV. The study includes a Screening period from Day -2 to Day -1, a Treatment period from Day 1 to Day 21, and a Follow-up visit around Day 50. Participants are randomly assigned to one of two groups one group receives weekly intravenous rezafungin infusions on Days 1, 8, and 15 combined with 7 days of oral or IV co-trimoxazole, while the other group receives co-trimoxazole alone for 21 days. Dosing adjustments for co-trimoxazole are made for participants with reduced kidney function. After the treatment period, all participants receive secondary prophylaxis against PCP following local guidelines. Throughout the study, participants will be monitored for adverse events and treatment response, including the rates of PCP relapse or immune reconstitution inflammatory syndrome. Safety assessments include vital signs, laboratory tests blood counts, chemistry, urinalysis, physical exams, and heart monitoring with ECGs. Medication use will be recorded. The total participation duration is approximately 52 days, ending with a follow-up visit to evaluate outcomes and safety.