Vancomycin-Resistant Enterococci (VRE) 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 drugs 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.

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 effectiveness of monotherapy versus combination antimicrobial treatments for patients with non-complicated Enterococcus faecalis bloodstream infection EF-BSI. This observational national multicenter study also aims to identify the gut microbiota fingerprint linked to EF-BSI and its relationship to antimicrobial treatments and patient outcomes. Enterococcus faecalis is a common gut bacterium that can cause serious bloodstream infections, and this study seeks to improve treatment strategies and understand the role of gut bacteria. The study compares appropriate single-drug therapy to combination antibiotic treatments, including drugs such as ampicillin, daptomycin, and newer cephalosporins like ceftaroline and ceftobiprole. It also assesses the clinical value of in vitro synergy tests that evaluate how well drug combinations work together. Participants receive at least five days of active antibiotic treatment, either alone or combined with synergistic drugs, following usual dosing guidelines. The study collects bacterial strains and monitors clinical outcomes up to six weeks after enrollment. Participants are monitored through bacterial culture analyses and gut microbiota assessments, with follow-up lasting up to three months. Researchers analyze genotypic and phenotypic traits of the bacteria and correlate these findings with treatment outcomes. The primary outcomes include clinical cure rates and validation of synergy testing. Secondary outcomes investigate the diversity of bacterial strains and changes in gut microbiota composition. This study provides detailed observation of treatment effects and gut microbiome changes in adults with EF-BSI.

Researchers are evaluating the effectiveness and safety of different approaches to screen for and remove Staphylococcus aureus SA bacteria before surgery. This study focuses on preventing SA colonization and surgical site infections in outpatients undergoing various surgeries, including orthopedic, urology, neuro, otolaryngology, plastic, general surgery, and OBGYN procedures. The trial aims to compare four different SA decolonization methods to see which best eradicates SA carriage and reduces infection risks. Participants are assigned to one of four groups Arm 1 involves screening for SA and giving a three-drug decolonization bundle nasal mupirocin ointment, chlorhexidine gluconate body wash, and mouth rinse for 5 days to those with SA, while non-carriers in this arm get two pre-op showers with chlorhexidine soap. Arm 2 gives all participants the three-drug bundle without screening. Arm 3 provides pre-op nasal povidone iodine on surgery day plus two pre-op chlorhexidine showers without screening. Arm 4 uses nasal alcohol gel on surgery day plus two pre-op chlorhexidine showers without screening. Participants will complete the decolonization protocol before surgery. Researchers will collect baseline cultures and assess eradication of SA from five body sites as the main outcome. Secondary outcomes include rates of SA surgical site infections and healthcare-associated infections. Monitoring includes verifying completion of the decolonization process and tracking infections. The study participation lasts from enrollment until surgery and includes follow-up to assess infection outcomes.

Researchers are evaluating whether oral vancomycin can prevent Clostridioides difficile infection C. diff in adults who are critically ill and at high risk due to their medical conditions and hospital stay. This trial also aims to understand the safety of vancomycin in this setting. The main questions are whether vancomycin lowers the infection rate and how carrier status of C. diff affects infection and clearance when vancomycin is used as primary prevention. Participants will be randomly assigned to receive either oral vancomycin 125 mg daily or a matching placebo while they are on systemic antibiotics, continuing up to five days after the last antibiotic dose, with the antibiotic treatment not exceeding 21 days. If discharged before completing the study medication, participants will continue taking it at home. Stool samples or rectal swabs will be collected to assess C. diff carrier status and changes in stool microbiome, including vancomycin-resistant Enterococcus VRE. During the study, participants will be monitored every three days until hospital discharge for adherence and side effects. After finishing the treatment, follow-up calls will be made to check for diarrhea or any adverse effects. The primary outcome is the rate of healthcare facility-onset C. diff infection, measured up to four months, along with secondary outcomes like VRE colonization, community-onset infections, time to infection in symptomatic patients, colonization at discharge, hospital stay length, and in-hospital mortality.

Researchers are evaluating how experiencing awe influences adults willingness to engage in prosocial preventive behaviors against infectious diseases. This randomized controlled trial includes adults from Hong Kong, Singapore, and ten major cities in Mainland China. The study aims to find out if feeling awe can increase intentions for actions like vaccination, mask-wearing, and social distancing, and whether these effects differ by location. Participants will be randomly assigned to one of two groups. The intervention group will play a three-step mini game called Hidden Picture Puzzle designed to induce awe by revealing nature scenes and reflecting on feelings evoked. The control group will play the same game format but will uncover everyday objects and describe their features instead. Each participant will complete four rounds of the game with different images. During the study, participants will complete the game and immediately report their intentions to engage in preventive behaviors and their choices in pandemic-related scenarios. The study will also assess intentions to participate in social activities after the game. The trial is conducted online, and participants had a baseline assessment about four months before the trial. The research team will monitor responses immediately after the game to measure the impact of awe on prosocial behavior.

Researchers are conducting a national, multicenter prospective study to understand how genetic defects and autoantibodies against type I interferons IFNs affect the immune response to infections, especially severe viral diseases like COVID-19. This study focuses on adults who either have inborn errors of immunity IEI impairing type I IFN responses or carry neutralizing autoantibodies against type I IFNs, which have been linked to severe illness and increased mortality in COVID-19. The aim is to track infectious, autoimmune, and cancer-related events to improve prevention and management strategies for these patients. The study includes adults with these immune characteristics who may be patients with past or current disease or healthy individuals such as blood donors or relatives of affected patients. Participants will have yearly visits to clinical centers for blood sampling and medical history updates, including investigations of immune markers, autoantibodies, and genetic analyses. Additional visits occur if participants experience infections, autoimmune flare-ups, cancer diagnoses, or COVID-19 infections, with detailed blood tests and teleconsultations. Controls without these immune abnormalities will be matched and followed through questionnaires and health data linkage. Participants undergo an initial visit to collect demographic information, medical and family history, and blood samples for detailed immune and genetic tests, including whole-exome or whole-genome sequencing. Follow-up visits occur annually for up to four years, involving clinical assessments and blood sampling to measure autoantibody levels and immune function. Clinical events and healthcare use will be tracked through national health data, and the main outcomes include measuring autoantibody levels and their neutralizing activity over time. This long-term monitoring aims to reveal factors influencing disease risk and immune changes in this population.

This research aims to determine if Infection Control Link Nurses ICLNs can improve nurses adherence to standard precautions, healthcare professionals hand hygiene, and reduce healthcare-associated infections. The study involves 8 hospital units randomized into two groups to compare the impact of trained ICLNs against usual infection prevention and control practices over 12 months. The trial evaluates whether this targeted nurse training can enhance infection control behaviors and outcomes in hospital settings. The intervention group includes 4 hospital medical-surgical wards and ICUs where one ICLN per unit receives ongoing education and leads peer training on infection control and hand hygiene. The control group consists of 4 hospital units continuing their standard infection prevention practices without ICLN involvement. The ICLN training program lasts 12 months with monthly meetings focused on healthcare-associated infection prevention, standard and isolation precautions, and hand hygiene. Participants are full-time nurses in the selected units who provide informed consent and complete a questionnaire measuring compliance with standard precautions at baseline and after 12 months. Data on healthcare professionals hand hygiene, alcohol-based hand rub use, and infection rates are collected concurrently by hospital staff. The study ensures privacy by analyzing and presenting data in aggregate form. Overall, the trial spans 12 months with evaluations at the start and end of the intervention period.

This clinical trial aims to investigate biomarkers involved in non-IgE-mediated immediate hypersensitivity reactions during intravenous vancomycin infusion. The study focuses on identifying new blood biomarkers that appear during these infusion reactions, which can help understand allergic responses to vancomycin. Healthy adult volunteers are the participants in this research conducted by Johns Hopkins University. Participants will receive a single infusion of intravenous vancomycin. Before the infusion, allergy skin testing for vancomycin will be performed to assess sensitivity. This study involves monitoring participants during and after the infusion to detect any hypersensitivity reactions and collect relevant biomarker data. During the trial, participants will undergo blood tests to measure serum vancomycin concentration about 30 minutes after infusion starts. Researchers will also monitor allergy responses and collect biomarker samples. Safety is closely observed, and participants will be required to meet specific health criteria before joining. The total duration of participation varies but includes screening, the infusion visit, and follow-up assessments as needed.

Researchers are studying how antibiotics behave in critically ill newborns, infants, and children who are on extracorporeal membrane oxygenation ECMO, a life-support technique. The goal is to understand if current dosing of several antibiotics used in pediatric patients on ECMO meets the desired drug concentration targets to fight infections effectively in a national multicenter setting. The study involves patients receiving one of these antibiotics as part of their regular care meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cefazolin, vancomycin, amikacin, teicoplanin, or ciprofloxacin. Blood samples, and in the case of ciprofloxacin also urine samples, will be taken during routine care to monitor antibiotic levels and evaluate pharmacodynamic targets. The study is non-randomized and includes multiple groups depending on the antibiotic received. Participants are pediatric patients up to 15 years old admitted to intensive care units and receiving ECMO. The study collects samples up to one month to measure how well the antibiotic concentrations reach target levels associated with fighting infection. Researchers will assess risks of underdosing or overdosing and monitor drug concentration patterns. The study is sponsored by University Hospital, Ghent, and will continue monitoring until 2026.