[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575248":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":45,"centralContacts":56,"locations":24,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":24,"maxAge":24,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":97,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":24},{"fullName":5,"class":6},"Institut Pasteur","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Febrile and non febrile children, pregnant women and new borns","OTHER","The study population is composed of children under the age of 5, which is also the population most at risk of malaria, living in the endemic areas of Lomé and Tsévié in Togo.",[13,14,15,16,17,18],"Other: Blood sample","Other: Urine sample","Other: oropharyngeal sample","Other: Optionnal : stool sample","Other: Optionnal : cerebrospinal fluid","Other: placental biopsy",[20,25,29,33,37,41],{"type":10,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Blood sample","For febrile children at the time of inclusion : 6.25 ml to 8.25 ml of blood ; For non febrile children at the time of inclusion : 4 ml of blood ; For pregnant women at the time of inclusion : 5 ml of peripheral blood, 5 ml of placental blood, 20 to 40 ml of umbilical cord blood ; For new borns : drop of blood on child's heel each month and 5 ml of blood the 12th and last month.",[9],null,{"type":10,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Urine sample","For febrile children : 10 ml of urine",[9],{"type":10,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"oropharyngeal sample","For febrile children : oropharyngeal swab sampling",[9],{"type":10,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Optionnal : stool sample","For febrile children (only as part of the care of the child) : 5g stool",[9],{"type":10,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"Optionnal : cerebrospinal fluid","For febrile children (only as part of the care of the child in case of suspected meningitis) : 4 additional drops of cerebrospinal fluid",[9],{"type":10,"name":42,"description":43,"armGroupLabels":44,"otherNames":24},"placental biopsy","For pregnant women : placental biopsy the size of 2 rice grains",[9],[46,49,53],{"name":47,"affiliation":5,"role":48},"Bich-Tram Huynh, PhD","STUDY_DIRECTOR",{"name":50,"affiliation":51,"role":52},"Luc Douti, MD","CHU-Campus de Lomé","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":52},"Serge Ekoué Gbadoe, MD","Hôpital de district Polyclinique de Zio-Tsévié",[57,61],{"name":47,"role":58,"phone":59,"phoneExt":24,"email":60},"CONTACT","+33 1 53 55 18 50","bich-tram.huynh@pasteur.fr",{"name":62,"role":58,"phone":63,"phoneExt":24,"email":64},"Celia Dechavanne, PhD","+229 99 35 05 98","celia.dechavanne@ird.fr",{"type":66,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[68],{"name":69,"class":70},"Institut de Recherche pour le Developpement","OTHER_GOV","100575248","host-immunity-plasmodium-and-pathogens-co-infections-100575248",false,"NCT06769815","Host Immunity, Plasmodium and Pathogens Co-Infections","HIPPI","Inclusion Criteria:\n\nFebrile children:\n\n* aged between 6 and 60 months\n* with a febrile episode lasting less than 7 days (axillary temperature \\>=37.5° Celsius)\n* whose state of health is compatible with a minimum single blood sample volume of 6.25 ml\n\nNon-febrile children:\n\n* aged between 6 and 60 months\n* with axillary temperature \\\u003C37.5° Celsius\n* no clinical signs of infection at the time of inclusion\n* no infectious episode or fever for 7 days\n\nPregnant women :\n\n* giving birth in the project's partner health center\n* intending to reside in the study area during the newborn follow-up period\n* with a mono-fetal pregnancy\n* With an apparently uncomplicated delivery not requiring referral to a higher-level health facility\n\nNewborns at delivery:\n\n* Born at term (determined by Ballard score)\n* whose parents or legal guardians reside in the study area during the newborn's follow-up period\n\nExclusion Criteria:\n\nFor all :\n\n\\- person already participating in another biomedical research project.\n\nFor febrile and non-febrile children:\n\n\\- chronic non-infectious pathology (cancer, malnutrition, etc.)\n\nFor pregnant women\n\n* scheduled caesarean section for current pregnancy\n* Caesarean section in previous pregnancies\n* chronic non-infectious pathology during pregnancy (diabetes, hypertension, pre-eclampsia)",true,"ALL",{"count":81,"type":82},2000,"ESTIMATED","INTERVENTIONAL",[85],"NA","Few studies have focused on malaria co-infections, mainly caused by Plasmodium falciparum, occurring mainly in children under 5 years of age in sub-Saharan Africa. These studies have focused on malaria-associated bacterial sepsis, with an estimated prevalence of 9.1% and associated mortality of 15.0%. However, no study has documented infectious sites other than the blood compartment, considered viruses and parasites as possible causes of infection in addition to bacteria, and used molecular diagnostic methods based on PCRs, which are more sensitive. Thus, the prevalence of these co-infections and the spectrum of pathogens involved are probably underestimated, as is the impact of these co-infections on mortality. Furthermore, it has been shown that malaria infections can condition the immune cells of naturally exposed individuals, potentially leading to greater susceptibility to all types of infection. But these mechanisms have never been documented in the context of co-infections.\n\nThe WHO recommends the use of broad-spectrum antibiotics in cases of severe malaria, in addition to antimalarial drugs, as it can be difficult to differentiate clinically between severe malaria and severe bacterial infection (bacteremia, pneumonia and meningitis). Yet this empirical use of antibiotics could be contributing to an increase in antibiotic resistance. Identifying the determinants of co-infection with malaria and severe bacterial infection would enable this treatment to be better targeted.\n\nThese determinants remain undetermined as no study has considered other causes of severe bacterial infection other than bacteremia, used appropriate statistical methodology (univariate analysis only) and explored important determinants, notably the capacity of children's innate immunity to respond to severe bacterial infection.",[88,89],"Malaria","Bacterial Co-infection",[91,92,93,94,95,96],"malaria","co-infection","immune response","epigenetic mechanisms","children","Togo","NOT_YET_RECRUITING","2025-01-21",{"date":100,"type":101},"2025-01-24","ACTUAL",{"date":103,"type":82},"2025-02-15",{"date":105,"type":82},"2027-08-15",{"name":5,"class":6}]