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Actively Recruiting
Blood cultures are blood tests used to detect infections, but collecting these samples can be challenging due to contamination and insufficient blood volume. This research evaluates whether using the PIVO Pro, a needle-free blood collection device that draws blood through an existing peripheral intravenous catheter (PIVC), reduces contamination compared to the standard blood collection method. The study focuses on adults aged 18 and older in emergency departments who require blood cultures to check for bloodstream infections. Participants will be randomly assigned to two groups: one using the PIVO Pro device to collect blood samples through the PIVC, and the other using the usual blood draw method. The PIVO Pro device advances a flexible tube through the catheter to obtain a fresh blood sample, potentially avoiding contamination and reducing the need for additional needles. The trial includes 1,148 adult participants across three emergency departments. During the study, participants will receive standard care, and researchers will collect information about blood sample collection and culture results from medical records. The main outcome measured is the success of blood culture draws without contamination, assessed at baseline. Additional measures include blood sample fill volume and quality, antibiotic use, and catheter-related complications. There is also a sub-study at one site focusing on catheter failure and vessel changes after blood draws.
Actively Recruiting
Researchers are investigating treatments for bloodstream infections caused by the bacterium Staphylococcus aureus, which can be deadly within three months of infection. This international, multi-center Phase 4 adaptive platform trial evaluates multiple treatment options simultaneously to identify those that reduce death rates within 90 days of infection. The trial adapts over time by assigning more patients to better-performing treatments, removing less effective ones, and adding new options, aiming to find the best combination of therapies for patients with this serious infection. Participants receive various antibiotic treatments such as Cefazolin, Penicillin, Clindamycin, Vancomycin or Daptomycin, as well as strategies like early switching to oral antibiotics. The trial also includes whole body FDG PET/CT imaging using standardized protocols to support diagnosis and treatment decisions. Patients are randomly assigned to different concurrent treatment options currently used in routine care, with ongoing adjustments based on accumulating results. During the study, participants undergo regular evaluations including blood culture monitoring to confirm infection clearance, clinical assessments, and imaging when applicable. Researchers track all-cause mortality up to 90 days after enrollment as the primary outcome. The trial infrastructure supports additional sub-studies, with patient safety and treatment effectiveness closely monitored throughout the trial period.