Staphylococcal Infection

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating the safety and how the body processes AZD7760 when given through an intravenous infusion. This study includes healthy adults in Phase I and adults with end-stage kidney disease who receive hemodialysis through a central venous catheter in Phase IIa. The purpose is to understand the safety and pharmacokinetics of AZD7760 in these two groups. In Phase I, participants will be randomly assigned to receive one of three doses of AZD7760 or a placebo as a single intravenous infusion on Day 1. This phase includes a 28-day screening period, a 3-day dosing period with one infusion, and a 12-month follow-up after treatment. In Phase IIa, participants with kidney disease will be randomly assigned to receive AZD7760 or placebo as two intravenous infusions 3 months apart, on Day 1 and Day 91, following a 28-day screening and a 12-month follow-up after the last dose. Participants will be monitored through regular assessments during screening, dosing, and follow-up periods. Researchers will track adverse events and measure drug levels in the blood over time. Safety evaluations include checking for any serious or special interest adverse events. The study lasts up to 12 months after the last drug administration, during which participants undergo physical exams, lab tests, and other monitoring to understand the effects and safety of AZD7760.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Researchers are evaluating the effect of adding clindamycin to the usual treatment of skin and soft tissue infections caused by Staphylococcus aureus in patients from Sierra Leone. The study aims to see if this combination leads to faster healing and fewer infection recurrences. These infections can be severe due to toxins produced by the bacteria, and clindamycin is believed to reduce these toxins. The trial compares standard treatment, usually involving anti-staphylococcal penicillin with or without surgery to drain infection, to the same treatment plus clindamycin. Clindamycin is given either orally or intravenously for 7 days, with dosing adjusted by weight. Participants receive either the standard care alone or the standard care plus clindamycin, and the study is open-label, meaning both patients and doctors know which treatment is given. Participants will be adults with confirmed Staphylococcus aureus skin infections who require systemic therapy. They will be monitored for clinical cure at 7 and 14 days, changes in inflammation, symptom resolution time, possible side effects, microbiological failure, and infections returning over 6 months. Follow-up visits may occur during hospital admission or at home, and safety and treatment outcomes will be carefully tracked throughout the study period.

Researchers are evaluating treatment options for patients with probable or definite prosthetic valve endocarditis caused by Staphylococcus aureus. The study aims to determine whether not giving rifampin, an antibiotic, is no worse than giving rifampin alongside standard care. This is a Phase 3 randomized clinical trial led by Todd C. Lee MD MPH FIDSA. Participants will be randomly assigned to one of two groups: one will receive adjunctive rifampin at a dose of 900 mg per day divided into 2-3 doses, while the other group will not receive rifampin. The study will follow participants for outcomes related to treatment success or failure, including monitoring for adverse reactions and other complications. During the trial, participants will be monitored for treatment failure over 180 days, including deaths, unplanned cardiac surgery, new embolic events, and relapse of bacteremia. Additional assessments within 56 days will track discontinuation of rifampin due to drug interactions or adverse reactions. Participants will be followed closely to evaluate safety and effectiveness throughout the study period, which extends up to 180 days after treatment begins.

This research focuses on understanding how antibiotics behave in the bodies of critically ill newborns, infants, and children aged from 1.8 kilograms up to 15 years who are admitted to pediatric intensive care. The study aims to evaluate if current dosing regimens achieve effective blood concentrations of antibiotics such as amoxicillin-clavulanate, piperacillin-tazobactam, vancomycin, teicoplanin, meropenem, ciprofloxacin, and amikacin. This information is important for guiding safe and effective antibiotic use in young patients under intensive care. Participants receive routine clinical care including treatment with one of the listed antibiotics administered through intermittent or continuous infusion. Blood, and in some cases urine, samples are collected from existing arterial or intravenous lines to monitor antibiotic levels. These procedures are performed during usual care without additional experimental treatments. During the study, patients will have their first-dose and steady-state blood concentrations of antibiotics measured and compared with targets for maximum antimicrobial activity. The study also collects urine samples for some antibiotics. Researchers aim to understand how well current antibiotic doses reach desired levels to guide future dosing strategies. Participation involves blood and urine sampling while receiving standard care, with safety monitored throughout the study period, which is expected to last approximately two years.

Researchers are evaluating the effects of clopidogrel compared to aspirin in patients with Staphylococcus aureus bloodstream infections who are already taking aspirin for secondary prevention of cardiovascular events. This open-label randomized controlled trial aims to determine if switching from aspirin to clopidogrel, which may have activity against S. aureus, can improve patient outcomes. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform (SNAP) trial and could lead to a future Phase 3 trial for broader populations. Participants will be randomly assigned to either stop aspirin and start clopidogrel without a loading dose or continue their current aspirin treatment. The trial is designed to compare these two approaches for cardiovascular risk reduction in the context of S. aureus infection. The treatment period coincides with enrollment in the SNAP trial, and patients are monitored throughout. During the study, researchers will assess outcomes at 90 days after enrollment in the SNAP trial, focusing on a ranking system called the Desirability of Outcome Ranking (DOOR). Additional measures include clinical failure, adverse events leading to treatment changes, mortality, infectious complications, bleeding events, thromboembolic events, strokes, heart attacks, and other arterial events. Participation involves regular monitoring and data collection as part of the SNAP trial protocol up to the study end date in January 2030.

Researchers are investigating whether adding ertapenem to cefazolin improves treatment outcomes in adults with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. This phase 2 randomized controlled trial builds on previous laboratory and animal studies, as well as small human case series, suggesting potential benefits of this drug combination. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform (SNAP) trial and aims to explore clinical success rates by day 5 of treatment. Participants receive either ertapenem 1 gram intravenously once daily infused over 2 hours for 5 days alongside cefazolin or a saline placebo infused daily over 2 hours for 5 days with cefazolin as standard therapy. The study uses quadruple masking to compare the effects of ertapenem plus cefazolin against cefazolin with placebo. The trial will monitor a variety of secondary outcomes including blood culture clearance at 30 days, clinical improvement, length of hospital stay, mortality, and infection complications over periods up to 90 days. Throughout the study, participants will have blood cultures and clinical assessments to evaluate infection clearance and treatment response. Researchers will also monitor for adverse events such as acute kidney injury or seizures within the first week. The total participation timeframe includes outcome assessments up to 90 days after treatment starts. This comprehensive monitoring will help determine if the combination therapy reduces bacteremia duration and improves patient outcomes without increasing risks.

Researchers are studying whether a nasal microbiota transplant (NMT) from parent to child can successfully transfer and establish beneficial bacteria in the noses of newborns, increasing the variety of microbes. This study focuses on neonates admitted to a neonatal intensive care unit (NICU), aiming to learn how different NMT approaches affect the baby's nasal microbiome. The study compares three groups: one receiving a single NMT, another receiving multiple NMTs, and a control group receiving a placebo sterile swab. Parents' nasal bacteria are collected and then transferred to the newborn's nose either once or multiple times, depending on the group. This transplant process is done after screening and consent. The research is conducted under phase 1 conditions, with random assignment but no masking. Participants and their parents will be monitored over two weeks after treatment, with nasal samples collected on days 2, 4, 7, 10, and 14 to measure the diversity of the neonatal nasal microbiome. The study involves screening for infections, consent procedures, and careful observation of the microbiome changes. The total age range for participants is from birth up to 60 years for parent providers, and the study runs through the end of 2026.

Researchers are evaluating whether benzylpenicillin is a better treatment than cloxacillin for adults with penicillin-susceptible Staphylococcus aureus bacteraemia (PSSA). This randomized controlled trial aims to compare these two antibiotics to see which leads to better outcomes, such as survival without complications, in patients with this bloodstream infection. The study is planned as a nation-wide effort involving adult patients over 18 years old. Participants will be randomly assigned to receive either benzylpenicillin or cloxacillin after confirming penicillin susceptibility of the bacteria from blood cultures, which typically takes two to three days. The dosage and treatment length depend on the specific infection diagnosis, such as endocarditis or arthritis. Both drugs will be given at recommended doses adjusted for kidney function when needed. The study includes repeated blood cultures and heart ultrasounds as part of the evaluation process to monitor infection and treatment effects. During the study, participants will be closely monitored for side effects like liver or kidney problems, rash, diarrhea, and blood vessel inflammation, as well as treatment failure, relapse, and survival over 90 days after treatment ends. Researchers will assess survival without complications, relapse rates, antibiotic changes due to side effects or treatment failure, and bacterial DNA levels in blood samples during the first five days. The total participation time covers treatment and follow-up for 90 days to evaluate outcomes and safety.