Leptospirosis

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 investigating whether adding a rapid biomarker test to current clinical guidelines can better identify young children with fever who are at risk of serious infections in sub-Saharan Africa. This study compares standard care based on integrated management of childhood illness (IMCI) guidelines alone to an approach enhanced by measuring suPAR levels, a biomarker, during the first clinical assessment. The goal is to see if this combined strategy improves decisions about hospital admission or discharge and leads to better health outcomes for children aged 2 to under 60 months. The trial is a multi-country, open-label, randomized study with two groups: one receiving the standard IMCI-based care and the other receiving IMCI care plus a point-of-care suPAR test. Blood samples will be taken from all children, but only the intervention group will have their suPAR levels measured immediately. Clinicians will use these results along with IMCI guidelines to decide whether to admit or discharge each child during the first clinical visit. A second, more detailed clinical assessment will also be performed on all participants to confirm or adjust decisions and ensure safety. Children will be followed up on days 3 and 7 after enrollment with additional visits if clinical worsening occurs. A day 28 follow-up will collect information on serious events, hospitalizations, or deaths, with an optional extra interview at three months. Participants with respiratory symptoms may join a substudy involving lung exams and sample collections. The study team will measure outcomes like the appropriateness of discharge decisions, hospital admissions, severity of illness, and mortality to evaluate the new triage approach's effectiveness and safety over these timeframes.

Researchers are conducting an international observational study to better understand acute infections in adults who are hospitalized. This study focuses on collecting data and biospecimens to characterize various infectious diseases, including respiratory infections, infections outside the respiratory tract, established infectious diseases, and newly emerging infections. The aim is to gather information that will help identify risk factors, clinical features, and management strategies, as well as to aid in designing future clinical trials. Participants include adults admitted to the hospital with suspected or confirmed acute infections. There is no intervention or treatment being tested, as this is an observational study. The research involves monitoring patients during their hospital stay to collect vital data and samples related to their infection. Participants will be observed over time, with researchers assessing outcomes such as mortality by day 28, time to recovery, clinical improvement by day 7, organ support-free days, and organ failure scores. Data collection includes clinical assessments and biospecimen sampling to better understand infection progression and patient recovery. The study begins in August 2025 and continues through June 2027, allowing for extensive data gathering and analysis.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are evaluating the safety and effectiveness of stopping antibiotic treatment early in adults hospitalized with respiratory viral infections. This study focuses on patients with moderately severe disease who test positive for respiratory viruses such as influenza, respiratory syncytial virus, parainfluenza virus, or human metapneumovirus. The goal is to determine if early discontinuation of antibiotics leads to similar clinical outcomes compared to continuing antibiotic therapy, aiming to reduce unnecessary antibiotic use and combat antimicrobial resistance. Participants are randomly assigned to either stop antibiotic therapy as started by their admitting physician or to continue antibiotic therapy without changes. The study monitors early clinical response at 120 hours after randomization, defined by survival with symptom improvement and no need for rescue antibiotics. Secondary assessments include mortality rates, hospital stay duration, antibiotic use, and readmission rates, all measured during hospital admission and up to 30 days after discharge. During the trial, participants undergo nasopharyngeal swab testing to confirm viral infection and are monitored closely for symptoms, survival, and antibiotic use. Researchers evaluate clinical response at 120 hours and track outcomes such as mortality, hospital stay length, and antibiotic doses until discharge and 30 days later. The study aims to gather detailed safety and efficacy data over the hospital stay and follow-up period, supporting more targeted antibiotic use in viral respiratory infections.

Delirium is a sudden state of confusion commonly seen in older adults admitted to hospitals, and identifying its cause quickly is important but often difficult. Infection may cause delirium, and many patients have bacteria in their urine, but bacteria alone do not always indicate a true infection. This trial studies whether antibiotics help treat delirium in adults aged 60 and older who have delirium and suspected urinary infection but no clear signs of urinary tract infection. Participants will be randomly assigned to one of two groups: one group will start or continue taking antibiotics prescribed by their main doctor, with the antibiotic type and treatment length decided by the doctor. The other group will not receive antibiotics. This randomized controlled trial compares these approaches to see if antibiotics improve delirium in this population. During the study, researchers will assess delirium at day 7 or when participants leave the hospital, whichever comes first. They will also monitor other outcomes like hospital stay length, blood infections, ICU transfers, falls, use of restraints or antipsychotics, antibiotic days, and infections such as C. difficile up to 30 days. Deaths and hospital readmissions will be tracked for up to one year. The study aims to provide clearer guidance on antibiotic use for delirium with suspected infection in older adults.

Leptospirosis is a bacterial infection transmitted to humans through contact with water or soil contaminated by animal urine, posing a significant public health concern. This research focuses on patients in Reunion, where leptospirosis is more common due to climate factors. The study aims to identify factors linked to the severity of leptospirosis and investigate long-term effects, including symptoms persisting beyond one year after infection. The study involves biological sampling including blood and urine collection for serology tests, freezing and storage of serum samples, and collecting clinical and biological data. Patients previously hospitalized with confirmed leptospirosis within 12 to 18 months are followed up. Two medical visits and two telephone interviews will assess quality of life and other health aspects over a year, with plans to monitor outcomes up to two years. Participants will have blood and urine samples collected and will be asked to complete telephone questionnaires. The study measures the proportion of patients experiencing chronic symptoms two years after infection, tracking clinical, serological, and quality of life outcomes. Data collection occurs through dedicated electronic forms, with participant follow-up lasting up to two years to better understand chronic manifestations of leptospirosis.

Researchers are creating a network of hospitals, labs, academic institutions, and healthcare organizations to provide annotated biospecimens for various types of medical research and education. These biospecimens will be used for biomarker discovery, diagnostic test development, therapeutics research, and training of researchers and physicians. Participants may be healthy or have medical conditions relevant to ongoing research needs. The study involves collecting remnant specimens originally obtained for clinical testing or specimens collected specifically for research, including biofluids, tissues, and cells. Participants may be identified during clinical care or recruited through outreach programs. Biospecimens may be distributed to various research entities such as academic institutions and companies for diverse research uses, including genetic testing, cell line development, and long-term storage. Participants may undergo minimal risk screening activities and provide biospecimens as needed. The research team will collect data over a 10-year period to support novel research uses. Biospecimens may be used for multiple research and educational purposes, including training laboratory technicians and physicians. The study includes participants aged 1 to 89 years and involves assessment of health status through medical record reviews and clinical exams when blood collection is needed.

This research involves using patient samples and clinical data for research and development or population-based analysis. It focuses on patients who have provided commercial samples to LabCorp or its affiliates, including those of scientific interest who may be followed up after giving informed consent. The study covers conditions related to pregnancy, cancer, and infectious diseases. The study has two groups: one uses leftover commercial samples and data that have been de-identified to protect personal health information for research purposes; the other involves collecting samples and data prospectively from patients who have given consent and are considered scientifically important by the sponsor or their doctor. Samples and data may be collected for up to 12 months after enrollment. Participants provide consent for their samples and data to be used or followed up if they are of scientific interest. Researchers will analyze these samples and data for research and development activities. The study tracks the use of remnant samples and data both retrospectively and prospectively, ensuring privacy compliance. Participation may include ongoing sample and data collection for up to one year after joining the study.

Access to safe drinking water remains a major challenge in rural households of developing countries, leading to millions of deaths annually due to unsafe water sources. This research evaluates a program that provides coupons for free dilute chlorine solution to improve child health by reducing diarrhea, fever, and cough incidents. The study is a large-scale randomized controlled trial conducted at health clinics, assessing the sustained health impacts and behavior related to chlorine use and health clinic visits. Participants are randomly assigned to receive coupons redeemable for a monthly supply of a 150ml bottle of dilute chlorine solution at registered health facilities for 12 months or to a control group that receives no coupons after enrollment. The intervention is delivered via SMS with an ID for coupon redemption after enrollment over a phone call. The study is conducted in collaboration with the Kenya Medical Research Institute at Health and Demographic Surveillance Systems sites. Participants are monitored for chlorine use in drinking water at 6-month intervals up to 36 months, along with assessments of child illness occurrences like diarrhea and fever. Data collection also includes child mortality and verbal autopsies for deceased children, providing valuable information for future studies on the mortality impact of chlorine distribution. The study involves ongoing data collection on self-reported health facility visits and objective measures of chlorine use over the study period.