[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548834":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":70,"collaborators":24,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Barcelona Institute for Global Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"L-citrulline","EXPERIMENTAL","1 or 2 sachets every 12 hours (200-300mg\u002Fkg\u002Fday depending on weight-band) for 28 days",[13],"Dietary Supplement: L-citrulline",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","1 or 2 sachets every 12 hours (depending on weight-band) for 28 days",[19],"Dietary Supplement: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":5,"role":30},"Quique Bassat, Prof","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":24,"email":35},"CONTACT","93 227 92 12","quique.bassat@isglobal.org",{"name":37,"role":33,"phone":34,"phoneExt":24,"email":38},"Barbara Baro, PhD","barbara.baro@isglobal.org",[40,56],{"facility":41,"status":42,"city":43,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hararghe Health Research","RECRUITING","Harar","Ethiopia","ET",{"type":47,"coordinates":48},"Point",[49,50],42.11815,9.31387,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":24,"phoneExt":24,"email":55},"Lola Madrid","Lola.Madrid-Castillo@lshtm.ac.uk",{"facility":57,"status":42,"city":58,"state":24,"zip":24,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Hospital Central de Maputo","Maputo","Mozambique","MZ",{"type":47,"coordinates":62},[63,64],32.58322,-25.96553,{"lat":64,"lon":63},[67],{"name":68,"role":33,"phone":24,"phoneExt":24,"email":69},"Chris Buck","WBuck@mednet.ucla.edu",{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100548834","l-citrulline-to-improve-adverse-outcomes-in-admitted-children-echilibrist-clinical-trial-2-inpatients-100548834",false,"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.","ALL","0 Months","60 Months",{"count":83,"type":84},2200,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90,91,92],"Infectious Disease","Infections","Child, Only","2026-02-19",{"date":95,"type":96},"2026-02-23","ACTUAL",{"date":98,"type":96},"2025-12-08",{"date":100,"type":84},"2027-08-01",{"name":5,"class":6},2]