Listeriosis

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 efficacy and safety of intravenously administered fosfomycin in treating severely infected patients across Europe. This prospective, multicenter, non-interventional study focuses on infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis or central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections covered by national guidelines. Patients receive fosfomycin intravenously according to the respective national Summary of Product Characteristics (SmPC). The study is observational and does not involve randomization or placebo. It includes monitoring during treatment and follow-up periods, with evaluations up to six months for treatment outcomes and up to one year for osteomyelitis follow-up. The study documents clinical and microbiological cure rates, clinical improvements, and sodium and potassium serum levels during hospital stays. Participants are assessed for clinical success at multiple points, including initial response (within 7 days), end of treatment (up to 6 months), test of cure, and follow-up (up to one year for osteomyelitis). Safety monitoring includes daily recording of adverse events, serious adverse events, adverse drug reactions, and deaths during treatment and follow-up. The study tracks dropouts due to treatment failure or adverse events. Overall, participation duration varies depending on treatment and follow-up schedules.

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.

Listeriosis is a rare and severe infection caused by the bacterium Listeria monocytogenes, mostly affecting older adults, people with weakened immune systems, and pregnant individuals. Some younger patients under 40 without known risk factors also develop serious forms, suggesting a possible genetic susceptibility. The MONALISA study is a national, ongoing case-control study initiated in 2009 to explore risk and prognosis factors of listeriosis, including genetic vulnerability. This study collects human biological samples such as blood, skin biopsy, and saliva from both patients diagnosed with listeriosis and their related volunteers. The genetic susceptibility to listeriosis is being investigated to better understand why some people develop severe or unusual forms of the infection. Volunteers related to patients may participate if a genetic susceptibility is identified in the patient. Participants provide samples and consent for genetic analysis over a period of 10 years. Researchers will identify genetic factors linked to susceptibility to listeriosis and its severe or atypical forms. The study aims to improve patient care through better treatment and prevention based on genetic findings. Participation includes providing biological samples and written consent, with ongoing observation and data collection.

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.

Inappropriate antibiotic prescribing in primary care contributes to antimicrobial resistance, especially when antibiotics are used for infections that usually resolve on their own. This research aims to evaluate a digital Prescription Support System (PSS) designed to help general practitioners in Belgium follow national guidelines for antimicrobial use during patient visits. The study uses a stepped-wedge cluster randomized design where general practices transition from usual care to using the PSS over four steps. The PSS integrates the Belgian BAPCOC guidelines into a user-friendly decision tree within electronic health records. It provides recommendations on antibiotic choice, dosage, duration, and when antibiotics are not needed for common infections seen in ambulatory care. Practices start with usual care and then sequentially gain access to the PSS, maintaining use for the remainder of the study. This digital tool aims to support prescribing decisions during routine consultations. Participants include general practices that use compatible electronic health records and consent to participate. The study monitors antibiotic prescribing rates quarterly using data from the Belgian Antibiotic Barometer for up to 12 months per practice. Researchers also assess the PSS's usability, acceptability, intensity of use, and any unintended effects reported by clinicians or observed in system data. Data privacy is ensured through pseudonymization and secure handling. Results will guide future improvements and broader implementation of the PSS in Belgian primary care.

Researchers are investigating the virologic and immunologic aspects of HIV infection, as well as other infectious and non-infectious immune deficiency diseases, to better understand the disease process of HIV. Due to the lack of suitable animal models, this research uses human peripheral blood cells to study HIV infection both inside the body and in laboratory settings. The goal is to clarify how HIV interacts with immune regulation and dysregulation using human peripheral blood mononuclear cells as a model. This observational study involves groups of people living with or without HIV, those with or without infectious diseases of interest, and individuals with or without immunodeficiencies. The study collects blood products and other biological samples to support various research projects conducted by NIH investigators. These samples will be used throughout the study to analyze HIV and immune-related parameters. Participants provide blood samples and undergo health assessments including blood pressure, pulse, and blood counts. They agree to blood being used for current and future research on HIV infection and pathogenesis, including hepatitis screening. The study measures genomic and proteomic properties of samples from individuals with HIV, infectious diseases, and immunodeficiencies, compared to healthy volunteers. Participation involves ongoing sample collection and monitoring by the NIH research team.