[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580661":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":23,"responsibleParty":45,"collaborators":47,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":7,"enrollmentInfo":64,"targetDuration":7,"studyType":67,"phases":7,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":76,"whyStopped":7,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","NG-TestⓇ Monkeypox virus kit","Evaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Mpox virus (NG-TestⓇ Monkeypox virus kit) and comparision with PCR result (reference test)",[14,20],{"name":15,"role":16,"phone":17,"phoneExt":18,"email":19},"Thierry NAAS, PhD","CONTACT","1 45 21 29 86","33","thierry.naas@aphp.fr",{"name":21,"role":16,"phone":17,"phoneExt":18,"email":22},"Saoussen OUESLATI, PhD","saoussen.oueslati@aphp.fr",[24,34,40],{"facility":25,"status":7,"city":26,"state":27,"zip":7,"country":28,"countryCode":7,"cosmosGeoPoint":7,"geoPoint":7,"contacts":29},"INRB","Mbandaka","Equateur","Republic of the Congo",[30],{"name":31,"role":16,"phone":32,"phoneExt":7,"email":33},"PLACIDE MBALA, PhD","+243 992 121 236","placidembala@inrb.net",{"facility":25,"status":7,"city":35,"state":36,"zip":7,"country":28,"countryCode":7,"cosmosGeoPoint":7,"geoPoint":7,"contacts":37},"Gemena","Sud Ubangi",[38],{"name":39,"role":16,"phone":32,"phoneExt":7,"email":33},"Placide MBALA, PhD",{"facility":25,"status":7,"city":41,"state":42,"zip":7,"country":28,"countryCode":7,"cosmosGeoPoint":7,"geoPoint":7,"contacts":43},"Bukavu","Sud-Kivu",[44],{"name":39,"role":16,"phone":32,"phoneExt":7,"email":33},{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[48,51],{"name":49,"class":50},"NG Biotech","UNKNOWN",{"name":52,"class":53},"Commissariat A L'energie Atomique","OTHER_GOV","100580661","diagramie-mpox-virus-rdc-for-the-diagnostic-of-monkeypox-100580661",false,"NCT06840197","DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox","Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - Mpox Virus Clinical Study in the Democratic Republic of the Congo - DiagRaMIE-Mpox Virus-DRC","DiagRaMIE Mpox","Inclusion Criteria:\n\n* Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases (https:\u002F\u002Fwww.who.int\u002Ffr\u002Fpublications-detail\u002FWHO-MPX-Surveillance-2022.3)\n* Persons aged 2 years and older:\n* An adult capable of providing informed consent to participate in the study\n* The legal guardian(s) capable of providing informed consent for the minor's participation in the study. For minors aged 12 to 17, their assent will also be required\n\nExclusion Criteria:\n\n* Refusal to participate by the individual or their legal guardian(s)\n* Person not capable of giving informed consent\n* Person with symptoms that appeared more than 14 days ago\n* Person presenting only with macules, papules, and crusts","ALL","2 Years",{"count":65,"type":66},197,"ESTIMATED","OBSERVATIONAL","Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC). This infection, primarily present in Central and West Africa, has an incubation period of 6 to 21 days and initially presents with fever, headaches, muscle pain, and swollen lymph nodes. This is followed by a skin rash that evolves over 2 to 3 weeks. Lesions can spread from the face to the hands, feet, and mucous membranes, with a centrifugal distribution pattern. Diagnosis is performed using PCR, based on samples taken from lesions or cutaneous exudates, although oropharyngeal swabs may be required if skin lesions are absent.\n\nSince May 2022, a resurgence of cases has been observed in North America, Europe, and Africa, including the DRC. As of March 2024, 94,270 cases and 178 deaths have been reported. Although less lethal than smallpox, with a mortality rate of 1% to 10% depending on the region, monkeypox remains a health threat, especially for young children and immunocompromised individuals. In response, the Commissariat à l'Énergie Atomique (CEA) and NG Biotech have developed the NG-TestⓇ Monkeypox virus rapid diagnostic test to facilitate detection. This antigenic immunochromatographic test, based on clinical samples, offers an alternative to PCR, providing rapid results without the need for costly equipment or specialized expertise. Its validation is underway for CE marking, enabling a swift response to potential health crises.\n\nPreclinical trials have confirmed that this test detects the Mpox virus with a detection limit of 1.10⁴ pfu\u002FmL and shows no cross-reaction with other common organisms. This clinical performance study aims to determine the effectiveness of this device using prospectively collected clinical samples. The study seeks to validate this rapid diagnostic test (RDT) and support its CE marking. Thus, this test could serve as an alternative to conventional PCR diagnostics, which require several hours to process and necessitate costly specialized equipment and expertise.",[70,71],"Mpox (Monkeypox)","Monkeypox Virus Infection",[73,74,75],"Mpox","Monkeypox virus","Rapid Diagnostic Test (RDT)","NOT_YET_RECRUITING","2025-02-17",{"date":79,"type":80},"2025-02-21","ACTUAL",{"date":82,"type":66},"2025-02",{"date":84,"type":66},"2025-05",{"name":5,"class":6},3]