Cholera

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.

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 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.