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 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.

Researchers are evaluating the safety, side effects, and effectiveness of brenipatide LY3537031 in adults with Irritable Bowel Syndrome-Diarrhea IBS-D. The study compares brenipatide administered under the skin with a placebo to understand its impact on this condition. This Phase 2 clinical trial involves participants aged 18 to 75 years. Participants will receive either the study drug brenipatide or a placebo through subcutaneous injections. The study follows a randomized, double-blind design where neither participants nor researchers know which treatment is given. Treatment and placebo administrations occur during the trial, which lasts approximately 35 weeks. During the study, participants will be monitored for how well they tolerate the drug and any side effects. Researchers will collect daily data on abdominal pain and stool consistency using an eDiary, focusing on responses between weeks 9 and 24. The primary measure is the percentage of participants achieving a daily composite response for at least half the days between weeks 9 and 16. Safety and efficacy outcomes are tracked throughout the trial period.

Researchers are evaluating the safety and preliminary effectiveness of SER-155, an experimental live bacterial therapeutic, as a first treatment for people experiencing diarrhea related to immunotherapy-induced enterocolitis irEC. This study focuses on adults with grade 2-3 diarrhea due to irEC who have not received immunosuppressive therapy before. The trial aims to find out if SER-155 causes few or mild side effects while addressing these symptoms. Participants will receive SER-155 orally, which consists of 16 unique human-commensal bacterial strains encapsulated for ingestion. The study is single-arm and open-label, meaning all participants will receive this experimental treatment without a comparison group. The treatment and observation will last up to one year, with assessments at various time points including days 15 and 43. During the study, participants will be monitored for treatment-related side effects and clinical responses to irEC without immunosuppressive drugs. Researchers will collect data on adverse events, treatment response and remission rates, and bacterial strain detection in the participants. The study involves regular assessments over a year to carefully track safety and treatment outcomes.

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 evaluating the GVGH Quadrivalent Pan-Salmonella vaccine in healthy adults aged 18 to 45 living in Africa. This Phase 1 study aims to assess the safety, side effects, and immune response triggered by the Pan-Salmonella vaccine, both with and without an aluminum hydroxide Alum component. The trial will help understand how the vaccine works in this population. Participants will be randomly assigned to one of five groups receiving different treatments low or full doses of the Pan-Salmonella vaccine with Alum, low or full doses without Alum, or a control group receiving placebo and the Typhoid Vi conjugate vaccine at specified time points. Vaccinations are given on Days 1, 61, and 181, with some groups receiving placebo only on Days 1 and 181 and the Typhoid vaccine on Day 61. Throughout the study, participants will be monitored closely for side effects at the injection site and systemic reactions during the week following each vaccination. Blood tests will be done to evaluate immune responses and check for any changes in blood, liver, and kidney functions at multiple time points. Safety assessments continue up to Day 361 to capture any serious adverse events and ensure participant well-being during the study period.

Researchers are studying the safety and effects of a medicine combining aztreonam ATM and avibactam AVI to treat infections caused by gram-negative bacteria in newborns and infants up to 9 months old who are hospitalized. This Phase 2a study includes two parts Part A focuses on a single dose, and Part B involves multiple doses, aiming to understand the medicines behavior in the body, safety, and how well it is tolerated. In Part A, hospitalized participants receive a single intravenous infusion of ATM-AVI over 3 hours, with blood samples taken during and after the infusion to study pharmacokinetics and safety. Part B participants receive multiple intravenous infusions every 6 to 8 hours for 3 to 14 days to treat suspected or confirmed infections and assess safety, pharmacokinetics, tolerability, and efficacy. Those with certain infections may also receive additional antibiotics, and participants with good responses may switch to oral antibiotics. The study includes 4 age cohorts and excludes overlapping participation between parts. Participants undergo blood level assessments, clinical evaluations at treatment end and test-of-cure visits, and safety monitoring up to 4 to 5 weeks after treatment. Researchers track adverse events, drug concentrations, and clinical outcomes. An independent committee oversees safety data. The total participation time is 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, childrens 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 interventions impact on infection and health.