Cholera

Researchers are evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are conducting an international observational study to understand acute infectious diseases in adults hospitalized with suspected or confirmed infections. This study aims to collect data and biospecimens from patients worldwide to characterize respiratory and non-respiratory infections, established infectious diseases, and emerging infectious diseases. The information gathered will help identify risk factors, clinical features, and management strategies, and guide future clinical trials. Participants in this study are adults admitted to a hospital with an acute infection or suspected infection. There is no intervention or treatment given as part of the study since it is observational. The study focuses on collecting clinical data and biospecimens during hospitalization to better understand the disease processes and outcomes. During the study, participants will be monitored for clinical outcomes such as mortality at 28 days, time to recovery, clinical improvement, organ support requirements, and organ failure scores. Data collection includes clinical assessments and biospecimen sampling. The study will continue until June 2027, with participants followed for outcomes mainly up to 28 days after enrollment. This observational approach supports the development of future clinical trials by providing detailed insights into acute infections.

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 effectiveness of the Case Area Targeted Interventions CATI approach in reducing cholera incidence among household contacts and neighbors within cholera hotspots in Dhaka city. This study focuses on administering the Oral Cholera Vaccine OCV either as a single dose or two doses one month apart, targeting individuals aged 1 year and older who are not pregnant. The study also explores the genome analysis and immune response to V. cholerae antigens in different hotspots. Cholera cases are identified by rapid diagnostic tests among diarrheal patients at icddr,b Dhaka Hospital, and hotspots are defined as households within a 20-40 meter radius around the index cases. Participants are enrolled in clusters averaging 150 individuals per hotspot area on the same day as the index case identification. The intervention involves giving either one dose or two doses of OCV, with children under 5 years receiving two doses 14 days apart per WHO guidelines. Passive surveillance for cholera cases will be conducted through icddr,b hospital and other health facilities throughout the study. Data on individuals infection states, such as susceptible or infectious, will be tracked during a three-year follow-up period. During the trial, participants will be monitored through passive surveillance and data collection on cholera incidence. The primary outcome measured is the number of culture-confirmed V. cholerae cases from enrollment through the three-year follow-up. The study involves signed informed consent, and eligibility criteria include age, pregnancy status, and vaccination history. The trial aims to provide insights into the effectiveness of rapid targeted vaccination in reducing cholera transmission in endemic urban settings.

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.

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.

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.