[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Barcelona Institute for Global Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":137},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,78,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100580181","preparing-for-maternal-gbs-vaccine-trials-in-africa-100580181",false,"NCT06833957","Preparing for Maternal GBS Vaccine Trials in Africa","PReparing for OptimalPhase III\u002FIV maTErnal Group B StreptococCal Vaccine Trials in Africa (PROTECT)","PROTECT","Inclusion Criteria:\n\n* WP2 Pregnancy Exposure Registries inclusion criteria:\n\nAll women and their infants attending for antenatal and\u002For delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.\n\nWP3 GBS Surveillance inclusion criteria:\n\n* Infants aged less than 90 days old with laboratory-confirmed GBS infection admitted at participating health facilities in Uganda, Malawi, Mozambique, and Kenya.\n* Infants whose parents or guardians provided written informed consent for their participation.\n* Residents in the catchment area of participating health facilities.\n\nWP4 Vaccine Confidence inclusion criteria:\n\n* In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age).\n* In Malawi, pregnant women aged 16 years are eligible to be included in the study because they are considered emancipated minors.\n* Pregnant women who consent to the study and give written consent.\n* Stakeholders who include pregnant women, health workers, women leaders, community leaders, national stakeholders, cultural and religious leaders who are willing to take part and can give written informed consent.\n\nExclusion Criteria:\n\nWP4 Vaccine Confidence exclusion criteria:\n\n* Pregnant women who are visiting\u002Fnon-resident in the research area.\n* Those who may be unwell and unable to consent to take part in the study.",true,"ALL",{"count":20,"type":21},18100,"ESTIMATED","8 Months","OBSERVATIONAL","Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.\n\nFortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths.\n\nThe PReparing for Optimal Phase III\u002FIV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \\& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines.\n\nThe end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.",[26,27,28],"Group B Streptococcus","Invasive Bacterial Diseases (IBD)","Maternal Immunization",[30,31,32,33,26,34,35,36],"Child health","Clinical research","Clinical trials","Infectious diseases","vaccines","maternal immunisation","maternal health","RECRUITING","2026-05-19",{"date":40,"type":41},"2026-05-20","ACTUAL",{"date":43,"type":41},"2025-03-01",{"date":45,"type":21},"2027-02-28",{"name":47,"class":48},"Barcelona Institute for Global Health","OTHER",10,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100548834","l-citrulline-to-improve-adverse-outcomes-in-admitted-children-echilibrist-clinical-trial-2-inpatients-100548834","NCT06426147","L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)","A Randomised, Double-blind, Placebo-controlled Trial of L-Citrulline Oral Supplementation to Improve Short and Long-term Outcomes of Admitted Febrile Paediatric Patients With Biomarker-determined High-risk of Adverse Outcomes","Inclusion Criteria:\n\n* Enrolled in the initial prognostic screening component.\n* Sick children with fever (axillary temperature\\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease.\n* 1m-\\\u003C60 months of age.\n* With an indication for admission, or having already been admitted to hospital due to their illness.\n* With an sTREM-1 PoC result classifying their disease as of \"moderate-high risk\" (\"yellow\" or \"red\") upon study recruitment and within D3.\n* Residents in the study area or willing to be contacted and traced during the study duration.\n* Willing to sign an informed consent document.\n* Willing to undergo and adhere to study procedures as explained in the IC document.\n\nExclusion Criteria:\n\n* Admission to hospital for social reasons (and not on account of their disease).\n* Children for which informed consent document has not been signed.\n* Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet.\n* Concurrent participation in any other clinical trial.\n* Patient under NPO or \"nothing by mouth\" prescription .\n* Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth.\n* Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening.\n* Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study.","0 Months","60 Months",{"count":60,"type":21},2200,"INTERVENTIONAL",[63],"NA","In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project (\"Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival\") has the two-fold objective of:\n\n1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the \"prognostic\" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and\n2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\\\u003C60 months identified as \"moderate-to-high risk\" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo.\n\nThis second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \\~888 children 1-\\\u003C60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg\u002Fkg\u002Fday depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia.",[66,67,68],"Infectious Disease","Infections","Child, Only","2026-02-19",{"date":71,"type":41},"2026-02-23",{"date":73,"type":41},"2025-12-08",{"date":75,"type":21},"2027-08-01",{"name":47,"class":48},2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":18,"minAge":85,"maxAge":58,"enrollmentInfo":86,"targetDuration":4,"studyType":61,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":77},"100548541","a-rapid-triage-test-to-improve-risk-stratification-of-febrile-children-echilibrist-clinical-trial-1-outpatients-100548541","NCT06422338","A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)","A Multi-country, Two-arm, Open-label, Superiority, Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care (IMCI-based) to Guide Admission\u002FDischarge Decisions During the First Clinical Assessment of Children With Fever","Inclusion Criteria:\n\n* Age ≥2 months and \\\u003C60 months\n* Written informed consent from the child's parent or caregiver\n* History of fever for ≤7 days OR hypothermia (i.e., axillary temperature \\\u003C35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition).\n* Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study\n* For the RTI sub-study only: presence of respiratory symptoms compatible with RTI.\n\nExclusion Criteria:\n\n* Weight less than 2.5kg\n* Main reason for consultation is an injury, trauma or acute poisoning\n* Enrolled in another clinical trial testing a new drug\n* Enrolled in a vaccine trial in the last 3 months.\n* Any other condition determined by the investigators that makes it unlikely that the participant would complete the study","2 Months",{"count":87,"type":21},5212,[63],"The overall aim of the study is to provide evidence that introducing novel biomarkers evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission\u002Freferral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.",[66,91,68],"Febrile Illness",[93,94,95,96,97],"biomarkers","severity","point-of-care","triage","sub-Saharan Africa","2026-02-12",{"date":100,"type":41},"2026-02-17",{"date":102,"type":41},"2025-07-02",{"date":104,"type":21},"2027-03-01",{"name":47,"class":48},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":17,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":116,"studyType":23,"phases":4,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100616949","questioning-the-epidemiology-of-asymptomatic-tb-100616949","NCT07312266","Questioning the Epidemiology of Asymptomatic TB","TB QUEST","Index cases:\n\nInclusion Criteria:\n\n1. 18 years of age or older\n2. Documented HIV infection\n3. Presenting at a health facility for routine HIV care\n\nExclusion Criteria:\n\n1. History of TB treatment in the last 12 months\n2. Pregnant women\n3. Refusal to provide consent for study procedures\n4. Contra-indication to any sampling procedure required by the study\n\nStudy 3 will utilize additional inclusion criteria:\n\nInclusion criteria:\n\n1. On ART for less than 6 months\n2. No evidence of viral suppression\n3. Documented CD4 count \\>350 copies\u002Ful\n4. TB-suggestive x-ray\n5. Verified absence of fever and cough, as ascertained through the symptom trackers\n\nContacts:\n\nInclusion criteria: All close contacts (household and close community contacts) will be offered to participate in the study, regardless of age or HIV status.\n\nExclusion criteria:\n\n1. Plans to migrate in the next 12 months\n2. Pregnant women\n3. Currently taking anti-tuberculosis treatment or preventive TB treatment\n4. Contacts with co-prevalent TB identified at baseline","18 Years",{"count":115,"type":21},6770,"12 Months","Tuberculosis (TB) remains one of the world's leading causes of morbidity and mortality. Current TB control strategies focus largely on the binary paradigm of TB, which tackle Mtb infection and the symptomatic stages of the disease as the major drivers of the TB epidemic. However, prevalence surveys have shown that about 50% of cases in which Mycobacterium tuberculosis is isolated from sputum but do not report having symptoms. Therefore, asymptomatic TB may play an important role in TB transmission. However, no field study has demonstrated direct transmission from a subclinical TB case to a confirmed secondary case.\n\nTB-QUEST is an ERC-funded epidemiological field study that aims to provide direct evidence of effective transmission from asymptomatic TB cases to their close contacts using advanced genomic methods, and to better characterize the asymptomatic stage of TB within the natural history of disease.",[119,120,121,122],"Tuberculosis","Tuberculosis (TB)","HIV","HIV (Human Immunodeficiency Virus)",[124,125,126,127],"Asymptomatic tuberculosis","Asymptomatic","Subclinical tuberculosis","Subclinical","2025-12-17",{"date":130,"type":41},"2025-12-31",{"date":132,"type":41},"2025-08-11",{"date":134,"type":21},"2029-05",{"name":47,"class":48},1,""]