Salmonella 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, tolerance, and side effects of brenipatide (LY3537031) in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). This Phase 2, randomized, double-blind, placebo-controlled study aims to compare brenipatide given under the skin with a placebo to assess its safety and effectiveness in treating IBS-D symptoms. The study is sponsored by Eli Lilly and Company and will last approximately 35 weeks. Participants will receive either brenipatide or a placebo via subcutaneous (under the skin) injections. The study includes two groups: one receiving the experimental drug LY3537031 and the other receiving a placebo, both administered in the same way. The treatment period and follow-up will be conducted over several weeks to evaluate the drug's impact on IBS-D symptoms. During the study, participants will record their symptoms daily using an electronic diary, focusing on abdominal pain and stool consistency. The main outcome measured is the percentage of days participants experience a significant improvement in their symptoms during weeks 9 to 16. Researchers will also monitor safety, side effects, and other symptom responses throughout the 24-week period. The study includes careful assessment of IBS-D criteria and symptom severity to evaluate treatment effects over time.

Researchers are evaluating SER-155, an experimental live bacterial therapeutic, as a first treatment option for people experiencing diarrhea due to immunotherapy-related enterocolitis (irEC). The study is a phase 1, open-label trial focused on assessing the safety and initial effectiveness of SER-155 in this group. This research is sponsored by Memorial Sloan Kettering Cancer Center and aims to find out if SER-155 causes few or mild side effects when used as a first treatment for irEC. Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for their condition will take SER-155 orally. This therapy consists of 16 unique bacterial strains encapsulated for oral use. The study will monitor participants over time to observe safety and preliminary efficacy, including responses and remission without the need for immunosuppressive drugs at days 15 and 43, as well as tracking the presence of SER-155 strains in stool samples. During the study, participants will be evaluated for treatment-related adverse events for up to one year. Researchers will also assess their clinical response and remission status at specific time points, monitor bacterial strain levels, and record the time to response or remission without immunosuppressive therapy. Participants will provide informed consent and comply with study protocols, including swallowing oral medication and using contraception if applicable. The total participation duration includes assessments up to one year after treatment begins.

Researchers are evaluating the safety, reactogenicity, and immune response of the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) vaccine in infants. The study focuses on administering the first dose either at 6 months of age or at 6 weeks of age. This Phase 2a trial aims to find the appropriate dose and schedule for the vaccine to protect against invasive nontyphoidal Salmonella disease and typhoid fever in infants in Africa. The study involves multiple groups of infants receiving different vaccine schedules and doses. Infants aged 6 months receive three doses of either a low or full dose of iNTS-TCV vaccine on Day 1, Day 85, and Day 337, or combinations of other vaccines including TYPHIBEV, Prevenar 13, and Nimenrix. Infants aged 6 weeks receive similar dosing schedules but with adjusted timing at Day 1, Day 57, and Day 232, including some groups receiving saline doses. The study includes control groups receiving licensed vaccines for comparison. Participants will be closely monitored throughout the study for side effects at the injection site and systemically, with assessments occurring within 7 days after each vaccine dose. Safety monitoring continues for up to 505 days for infants starting at 6 months and 400 days for those starting at 6 weeks. Blood tests will measure immune responses before and after vaccinations, evaluating antibodies against Salmonella and typhoid antigens. The study includes detailed laboratory assessments and tracking of any adverse events or serious complications during the follow-up period.

Researchers are studying the safety and effects of a medicine combining aztreonam and avibactam (ATM-AVI) for treating infections caused by gram-negative bacteria in newborns and infants under 9 months old admitted to hospitals. This Phase 2a study aims to understand how the medicine behaves in the body and how well it is tolerated. It includes hospitalized infants with suspected or confirmed bacterial infections requiring intravenous antibiotics. The study has two parts. In Part A, participants receive a single intravenous infusion of ATM-AVI over three hours to assess safety, tolerability, and drug levels without treating the infection. In Part B, participants receive multiple intravenous infusions every 6 to 8 hours for 3 to 14 days as treatment for their infection, with some also receiving metronidazole or other antibiotics as needed. Blood samples and clinical responses are monitored during and after treatment. Participants will undergo blood tests to measure ATM-AVI levels and safety assessments during treatment and up to 5 weeks after infusion. Clinical responses to treatment are evaluated at the end of intravenous therapy, oral antibiotic switch if applicable, and at a test-of-cure visit 7 to 14 days post-treatment. An independent committee will oversee safety, and the total participation lasts about 5 weeks for Part A and up to 7 weeks for Part B.

Researchers are studying children aged 6 months to 5 years who have acute gastroenteritis, a common cause of dehydration and emergency visits. The study compares two types of intravenous fluids used for rehydration: normal saline, which has a high chloride content, and balanced crystalloids like Isolyte-S, which contain acetate and gluconate to help neutralize acid. The goal is to see if balanced fluids improve blood bicarbonate levels and other clinical outcomes compared to normal saline. The study observes children who receive either normal saline or the balanced crystalloid Isolyte-S as part of their routine care, with the treating physician deciding which fluid to use independently. No additional tests or treatments are given for research purposes. Data are collected at baseline when fluids start, about 4 hours later from routine blood tests, and 72 hours after discharge to check for return visits. During participation, children's blood tests taken as part of standard care are reviewed to evaluate changes in serum bicarbonate, blood pH, chloride levels, and other measures like time to first oral intake and hospital admission. Researchers also track if additional IV fluid boluses are needed and monitor for emergency return visits within 72 hours. The study lasts through these observation points without extra procedures beyond usual care.

Researchers are evaluating new home-based methods to measure medication and chemical concentrations in sweat and saliva compared to standard blood tests in patients with chronic or infectious diseases who are receiving medications. The study aims to see if a smart wristband can accurately monitor substances like electrolytes and metabolites in sweat, which may help in health monitoring and disease diagnosis. This pilot observational study is focused on assessing the feasibility of these wearable sweat sensors. Participants provide sweat samples using a Macroduct Sweat Collection System, saliva samples, and blood samples within 24 hours after taking their medications. They also complete short questionnaires lasting 5 to 10 minutes and allow their medical records to be reviewed. The study collects samples and data to compare the new home-based methods against the standard liquid chromatography-mass spectrometry of plasma. During the study, patients are followed periodically after completing sample collection to monitor results and assess feasibility. Researchers measure how well the home-based sampling predicts medication levels and observe plasma concentrations within 4 hours. The study includes ongoing follow-up to evaluate the ease of obtaining home-based samples and to review medical data over time.

Researchers are evaluating the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI) to reduce cholera infections and promote lasting WASH behaviors in areas near cholera cases in Bangladesh. Cholera causes millions of infections globally each year, and this study focuses on people living close to cholera patients who are at much higher risk during the first week after the patient receives care. The study aims to find scalable ways to deliver effective WASH interventions to these high-risk communities. The study involves three phases: development and planning of the intervention using interviews and pilot testing, implementation and evaluation through a randomized controlled trial, and dissemination of findings for policy planning. Participants in the trial will be divided into two groups. One group receives the usual advice on oral rehydration and a WASH leaflet during a single visit. The other group participates in group sessions led by a health promoter who teaches about diarrhea spread, handwashing, water treatment, and safe water storage. These households also receive a cholera prevention package and weekly voice and text messages for 12 months promoting WASH behaviors. Water and clinical samples will be analyzed to study cholera transmission. Participants will be followed for one month to track new cholera infections and for 12 months to observe diarrhea cases and WASH behaviors. Data collected includes handwashing frequency, water quality, psychosocial factors, and child growth assessments. The study measures the number of cholera infections in the participant rings around cholera cases as the primary outcome. Safety monitoring and long-term follow-up are integrated throughout the trial, which is expected to provide important evidence on controlling cholera through targeted WASH interventions.

This research aims to evaluate the effects of a multi-component chlorination intervention on maternal and neonatal health in public healthcare facilities in western Kenya. The trial focuses on reducing bacterial contamination and antibiotic-resistant infections in neonates born at these facilities. The study is a cluster randomized controlled trial involving 36 health facilities, with a goal to provide evidence on how chlorinated water supply and reliable chlorine disinfectant use impact bacterial contamination and infection rates. Health facilities will be randomly assigned either to a control group or to an intervention group. Intervention facilities will receive passive inline chlorine dosers that automatically treat water used in maternity wards, along with a steady supply of chlorine disinfectant. Half of the intervention sites will produce chlorine on-site using electrochlorinators, while the other half will receive bulk chlorine deliveries. Both intervention and control facilities will receive infection prevention and control messaging. Facilities will also get equipment like mops and spray bottles for surface cleaning. Participants include pregnant adults or mature minors giving birth at enrolled facilities and their newborns. Researchers will collect data over 24 months, assessing bacterial contamination in water, on hands, and on surfaces, as well as gut colonization by pathogenic and antibiotic-resistant bacteria in mothers and neonates. Health outcomes like possible serious bacterial infection and sepsis symptoms will be monitored during the first week after birth. The study will also track neonatal and maternal mortality up to 28 days postpartum to understand the intervention's impact on infection and health.

Researchers are evaluating the clinical and antibacterial effects, safety, and pharmacokinetics of the drug Fluorothiazinone compared to a placebo for preventing hospital-acquired gram-negative bacterial infections in patients who are on mechanical ventilation. The study is a randomized, double-blind, placebo-controlled clinical trial conducted by the Gamaleya Research Institute of Epidemiology and Microbiology. Participants are randomly assigned to receive either Fluorothiazinone tablets or a matching placebo. Those in the treatment group take 2400 mg per day (4 tablets twice daily) for the first two days, then 1800 mg per day (3 tablets twice daily) from day three onward for up to 14 days or until ventilator-associated pneumonia caused by gram-negative bacteria develops. Tablets are taken twice daily, 12 hours apart, 30 minutes after meals. The placebo group follows the same dosing schedule with inactive tablets. During the study, participants are monitored for the development of pneumonia, bloodstream infections, and urinary tract infections associated with mechanical ventilation over a 14-day therapy period. Researchers track the time to infection onset, the proportion of patients affected by infections or septic complications, and any fatal outcomes. Safety, tolerability, and blood levels of Fluorothiazinone are also evaluated. The study includes adult patients in intensive care units who have been on mechanical ventilation for no more than 12 hours and are at high risk of requiring ventilation within 72 hours.