Passos

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Healthcare-associated infections (HAIs) are a major issue in intensive care units (ICUs), often caused by contamination with multidrug-resistant organisms that remain despite routine cleaning. This trial evaluates different surface disinfection methods to reduce such contamination and improve patient outcomes. It is a cluster-randomized, crossover study conducted in 12 Brazilian ICUs, comparing usual cleaning methods with additional disinfection technologies. The trial involves three sequential strategies in each ICU: usual surface disinfection alone; usual disinfection followed by aerosolized hydrogen peroxide sprayed at 7.9% concentration inside a protective tent during terminal cleaning of patient beds; and usual disinfection followed by automated ultraviolet-C light irradiation applied under the same protective tent to disinfect beds and nearby surfaces. These methods are compared to assess their impact on infection control. Participants admitted to the ICUs will be monitored for antimicrobial use, which is the primary outcome measured as daily defined doses per 100 patient-days over three months. Secondary outcomes include rates of HAIs, environmental contamination by resistant organisms, specific infection types like ventilator-associated pneumonia, bloodstream infections, urinary tract infections, and ICU length of stay and costs. The study includes assessments of contamination and infection rates during each intervention period to evaluate effectiveness and safety.

Researchers are investigating whether an educational quality improvement intervention can reduce the use of antimicrobials in adult patients admitted to intensive care units (ICUs) in Brazil. This trial focuses on critically ill patients and aims to see if training ICU doctors and healthcare professionals to follow updated guidelines can decrease antimicrobial consumption without negatively impacting ICU mortality rates or length of stay. The study is designed as a stepped-wedge cluster randomized trial involving 10 ICUs participating in a larger registry focused on ICU infections and antimicrobial use. The intervention includes educational sessions, an operations manual, and cognitive aids to help ICU physicians make better decisions about starting, reviewing, and stopping antimicrobials based on current recommendations. Each ICU will receive an initial site visit to deliver training and assess local barriers to implementation. Following this, monthly one-day audits will be performed to monitor antimicrobial use and provide feedback to the ICU teams. The study includes a baseline period before the intervention, a phased implementation over 10 steps starting in July 2025, and a three-month phase-out period to observe if benefits persist after active feedback stops. Participants will be adult patients admitted to the ICUs during the study period. Data collection includes monthly point-prevalence surveys of antimicrobial use and routine information from the existing ICU registry. Researchers will evaluate antimicrobial utilization at the ICU level over 14 months, monitoring safety outcomes such as ICU mortality and length of stay. The total participation for each ICU spans from baseline through intervention and phase-out periods, with ongoing data analysis to assess the intervention's impact.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.

Researchers are evaluating whether patients with ventilator-associated tracheobronchitis (VAT) in intensive care units benefit from a 7-day course of antibiotics compared to clinical observation without antibiotic treatment. This trial is a national, multicenter, single-blinded, randomized non-inferiority study aiming to determine if monitoring without antibiotics is as effective as antibiotic therapy for VAT, given the current uncertainty and conflicting guidelines about antibiotic use for this condition. Participants diagnosed with VAT will be randomly assigned to one of two groups. One group will receive standard care plus a 7-day antibiotic course, while the other group will have clinical observation without antibiotics unless they develop new organ dysfunction or infections other than VAT. The study focuses on comparing these two approaches to see if withholding antibiotics is noninferior in managing VAT. During the study, patients will be monitored for ventilator-free days within 28 days after randomization. Researchers will assess clinical status, chest imaging, and tracheal secretion cultures. Safety and treatment effects will be carefully tracked, with data analysis conducted in a blinded manner. The trial encompasses ICU patients who have been mechanically ventilated for at least 48 hours and meet specific clinical and laboratory criteria for VAT.