[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642705":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":23,"locations":33,"responsibleParty":75,"collaborators":78,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":7,"enrollmentInfo":114,"targetDuration":7,"studyType":117,"phases":7,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":47,"whyStopped":7,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",null,[9,13,17,20],{"name":10,"affiliation":11,"role":12},"Aman Russom, PhD","KTH Royal Institute of Technology","STUDY_CHAIR",{"name":14,"affiliation":15,"role":16},"Juliet Mwanga-Amumpaire, MD, PhD","Epicentre Mbarara Research Centre","PRINCIPAL_INVESTIGATOR",{"name":18,"affiliation":19,"role":16},"Adane Mihret, DVM, MSc, PhD","Armauer Hansen Research Institute, Ethiopia",{"name":21,"affiliation":22,"role":16},"Cheikh Fall, PhD","Institut Pasteur de Dakar",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":7,"email":28},"Devanshi Pandit","CONTACT","+44 (0)1234 780020","Devanshi.Pandit@globalaccessdx.com",{"name":30,"role":26,"phone":31,"phoneExt":7,"email":32},"Giulia Gaudenzi, PhD","+46 76 3446161","giulia.gaudenzi@ki.se",[34,46,61],{"facility":35,"status":36,"city":37,"state":7,"zip":7,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":7},"Armauer Hansen Research Institute (AHRI)","COMPLETED","Addis Ababa","Ethiopia","ET",{"type":41,"coordinates":42},"Point",[43,44],38.74689,9.02497,{"lat":44,"lon":43},{"facility":22,"status":47,"city":48,"state":7,"zip":7,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"RECRUITING","Dakar","Senegal","SN",{"type":41,"coordinates":52},[53,54],-17.44406,14.6937,{"lat":54,"lon":53},[57,60],{"name":21,"role":26,"phone":58,"phoneExt":7,"email":59},"+221 77 649 23 87 |","cheikh.fall@pasteur.sn",{"name":21,"role":16,"phone":7,"phoneExt":7,"email":7},{"facility":15,"status":47,"city":62,"state":7,"zip":7,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Mbarara","Uganda","UG",{"type":41,"coordinates":66},[67,68],30.64851,-0.60467,{"lat":68,"lon":67},[71,74],{"name":14,"role":26,"phone":72,"phoneExt":7,"email":73},"+256 794 046757","juliet.mwanga@epicentre.msf.org",{"name":14,"role":16,"phone":7,"phoneExt":7,"email":7},{"type":16,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Tobias Alfvén","MD, PhD",[79,80,83,84,86,88,90,92,94,96,98,100,102],{"name":11,"class":6},{"name":81,"class":82},"Institut Pasteur, Dakar, Sénégal","UNKNOWN",{"name":19,"class":6},{"name":85,"class":82},"Epicentre Mbarara Research Center",{"name":87,"class":82},"Global Access Diagnostics (GADx)",{"name":89,"class":82},"MAST Diagnostica Gmbh",{"name":91,"class":6},"Makerere University",{"name":93,"class":82},"Hahn Schickard",{"name":95,"class":6},"Teesside University",{"name":97,"class":82},"BLUMORPHO SAS",{"name":99,"class":82},"iSTOC OY",{"name":101,"class":6},"University of Freiburg",{"name":103,"class":6},"Stockholm University","100642705","holistic-approach-supporting-the-uptake-of-innovative-diagnostic-technologies-for-respiratory-infections-100642705",false,"NCT07651865","Holistic Approach Supporting the Uptake of Innovative Diagnostic Technologies for Respiratory Infections","Clinical Validation of Novel Microfluidic and Lateral Flow-based Technologies for the Detection of Lower and Upper Respiratory Tract Infections - HOLICARE Trial","HOLICARE","Inclusion Criteria:\n\n* Age ≥ 6 months\n* Presentation with suspected respiratory tract infection and at least two of the following symptoms:\n* Fever (axillary temperature ≥37.5°C) or history of fever\n* New acute cough episode\n* Shortness of breath\n* Tachypnoea (fast breathing)\n* Loss of smell and\u002For taste\n* Ability to provide written informed consent (or assent with parent\u002Fguardian consent for minors)\n* For infants (≤1 year), both fever and new acute cough must be present at screening\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent\u002Fassent\n* Refusal to provide study samples\n* Severe chronic medical conditions or mental incapacity that, in the opinion of the clinician, would interfere with study participation\n* Hospitalisation within the previous 2 weeks for reasons unrelated to the current respiratory symptoms\n* Acute injury, trauma, or poisoning interfering with participation\n* Chronic cough lasting \\>2 weeks, unless tuberculosis is suspected in the LRTI cohort\n* Antibiotic use within the previous 2 weeks for participants enrolled in the LRTI cohort (Sub-study 2) only","ALL","6 Months",{"count":115,"type":116},2160,"ESTIMATED","OBSERVATIONAL","This observational diagnostic validation study aims to evaluate the clinical performance of novel lateral flow and microfluidic-based technologies for the detection of upper and lower respiratory tract infections in children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. The main questions it aims to answer are:\n\n1. whether the novel multiplex lateral flow tests and point-of-care microfluidic platform demonstrate sufficient sensitivity and specificity for detecting respiratory pathogens compared with standard laboratory reference methods, and\n2. whether these technologies are feasible and usable in low-resource clinical settings.\n\nParticipants presenting with suspected respiratory tract infections as part of routine clinical care will provide respiratory and blood samples for diagnostic testing and biobanking, and demographic and clinical information will be collected during a single study visit. Some adult participants and community stakeholders will also complete surveys or interviews regarding the acceptability of biobanking and diagnostic implementation.",[120,121],"Upper Respiratory Infection","Lower Resp Tract Infection",[123,124,125,126,127,128],"Point of Care","POC","Later Flow Test (LFT)","Global Health","Rapid diagnostic","Microfluidics","2026-06-24",{"date":131,"type":132},"2026-06-29","ACTUAL",{"date":134,"type":132},"2025-04-07",{"date":136,"type":116},"2026-08-31",{"name":5,"class":6},3]