Redcliffe

Researchers are evaluating various treatment strategies for Gram-negative bloodstream infections GN BSIs in a large, ongoing platform trial called BALANCE. This trial aims to improve treatment methods, patient outcomes, and reduce antimicrobial resistance. It builds on previous research and uses an adaptive design to answer critical questions about managing these serious infections in hospitalized patients. The trial studies different treatment approaches including antibiotic de-escalation, oral beta-lactam versus non-beta-lactam antibiotics, whether to replace or retain central vascular catheters, selecting cephalosporins or carbapenems for specific bacteria, and the use of routine follow-up blood cultures. Participants are randomly assigned to one of these treatment strategies within each domain, with ongoing adjustments based on interim analyses. The initial pilot study has completed, and all patients from that phase are included in the main trial. Participants will be monitored over 90 days for outcomes including death, reinfection, hospital readmission, and development of new antimicrobial resistance. Evaluations include laboratory tests, clinical assessments, and tracking of antibiotic use and patient health status. The trial uses a ranking scale combining these outcomes to determine the desirability of each treatment strategy. This adaptive platform design allows continuous learning and refinement of treatments to improve care for people with GN BSIs.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

This trial investigates whether fluid therapy with Plasma-Lyte48 increases the number of days alive and out of hospital by day 28 compared to 0.9% sodium chloride saline in critically ill patients with moderate to severe diabetic ketoacidosis DKA admitted to emergency departments and critical care units. DKA is a serious complication of diabetes, and hospital admissions for this condition have risen notably in recent years. Current treatment guidelines rely on limited evidence, creating a need for clearer information on the best fluid therapy approach. Participants receive either Plasma-Lyte48 or 0.9% saline as intravenous fluids for resuscitation during two 12-month periods across 20 hospitals, with a one-month break between periods. Each hospital switches fluids after the first period. The fluids are blinded and provided by Baxter Healthcare, with treatments continuing until discharge from critical care or up to 72 hours. Additional therapies, including glucose solutions and electrolyte supplements, are used as needed based on clinical judgment. During the study, patients are monitored for hospital-free days up to 28 days after enrollment, with telephone follow-up to collect information. Secondary outcomes include ICU-free days, readmissions, kidney function, mental status changes, ketosis resolution time, insulin use, and potassium replacement. The study involves consumer representatives and aims to provide evidence to improve DKA management. Total participation involves treatment and follow-up over 28 days post-enrollment.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

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.

Researchers are investigating the best treatment approaches for infections in artificial hip and knee joints. This study compares different surgical methods, antibiotic choices, and durations of antibiotic treatment to determine which combinations lead to the best outcomes and cure rates at 12 months. The trial focuses on adults with infected artificial joints and aims to address the significant health and economic impacts of prosthetic joint infections. Participants may receive one of several surgical strategies cleaning the infected joint without removing the implant DAIR, or revision surgery where the infected implant is replaced either in a single operation or two stages. Antibiotic treatments are also compared, with some participants receiving standard antibiotics alone and others receiving additional rifampicin. The study further explores different lengths of antibiotic courses after revision surgery, including shorter and longer durations and extended prophylaxis after two-stage revisions. During the study, participants consent to have their medical and treatment information collected in a central database and registry. Researchers will assess health status, infection cure, joint function, quality of life, and antibiotic use at 100 days and 12 months after starting the study. Outcomes like reinfection, survival, and revision surgeries will be monitored up to two years. This study does not require extra tests or treatments beyond routine care and follows participants closely to evaluate treatment success and safety.

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.