Robina

This research aims to evaluate a new delivery method of spinal cord stimulation using the Evoke System for patients with chronic pain in the trunk andor limbs. The study focuses on a novel approach called ECAP-controlled closed-loop spinal cord stimulation, which includes new software and hardware features to better manage pain. The trial is designed as a prospective, multicenter, single-arm feasibility study sponsored by Saluda Medical Pty Ltd. Participants will receive treatment with the Evoke Spinal Cord Stimulation SCS System, which continuously measures and records evoked compound action potentials ECAPs and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. This closed-loop system aims to provide a more personalized and controlled pain management experience. The study includes only one experimental treatment group using this device. During the study, participants will be closely monitored for changes in ECAPs as measured by the Evoke SCS System through the completion of the study, which can last up to two years. Assessments will focus on the devices performance in controlling pain signals, with ongoing evaluations to track the stability and effectiveness of the stimulation. Participants will provide informed consent and comply with study requirements throughout their involvement.

Researchers are evaluating the PIVO Pro needle-free blood collection device to reduce contamination in blood culture samples for patients suspected of bloodstream infection. This trial focuses on patients aged 18 and older who need blood culture tests in emergency departments. The goal is to compare contamination rates between the PIVO Pro device and the usual blood sampling methods, addressing issues like contamination and insufficient blood volume that affect test accuracy. Participants will be randomly assigned to either the PIVO Pro group or the control group using standard blood draw methods. The PIVO Pro device collects blood through a peripheral intravenous catheter by advancing a flexible tube beyond the catheter tip, aiming to obtain cleaner samples with less contamination. The control group will have blood drawn by usual methods like venepuncture or direct catheter draw. The trial includes an additional sub-study at one site examining catheter-related complications following blood draws. During the study, participants will receive standard care with no extra procedures required. Researchers will collect data on blood culture results, contamination rates, blood sample volume, and antibiotic use from medical records. Outcomes such as blood culture success without contamination and overall sample quality will be measured. The study will monitor participants for up to one week after blood collection to assess antibiotic use and catheter complications, ensuring safety and thorough evaluation over the trial period.

The trial investigates treatments for bloodstream infection caused by Staphylococcus aureus SAB, which can be life-threatening with a 15-30% death rate within three months. This international, multi-center randomized adaptive platform trial aims to find the best treatment options to reduce mortality within 90 days of infection. The trial adapts over time by assigning more patients to treatments that show better outcomes and removing less effective options. Participants receive various antibiotic treatments depending on their group. These include intravenous vancomycin or daptomycin, flucloxacillin or cloxacillin, cefazolin, or benzylpenicillin, with dosages adjusted for kidney function or illness severity. Some receive adjunctive drugs like clindamycin, and others may switch from intravenous to oral antibiotics if eligible after 7 or 14 days. Additionally, some participants undergo PETCT scans as part of the study. During the study, participants are monitored closely with blood cultures, temperature checks, and clinical assessments to track infection clearance and complications. Researchers measure all-cause mortality at 90 days as the primary outcome, along with other outcomes such as survival at earlier time points, hospital stay length, microbiological treatment failure, serious reactions, and antibiotic use. Safety and health economic data are also collected to evaluate treatments comprehensively throughout the trial.