[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656083":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":41,"overallOfficials":53,"centralContacts":61,"locations":67,"responsibleParty":89,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":22,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":118,"whyStopped":22,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Centre de Recherche Médicale de Lambaréné","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants in whom the parasitaemia was cleared","No parasites detected in the thick blood smear (microscopic method)","On day 7 from the first day of treatment",[14,18],{"measure":15,"description":16,"timeFrame":17},"Number of participants cured","Defined as the absence of Plasmodium infection (including reinfections) following treatment, as determined by microscopy and adjusted by PCR, in the per-protocol and intention-to-treat populations.","From the last day of treatment (day 7) to the end of the follow-up period on day 28",{"measure":19,"description":20,"timeFrame":21},"Number of adverse events","Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety","From the first day of treatment (enrolment) to the end of the treatment period on day 7",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","For safety reasons, participants will be followed up daily for malaria-like symptoms and parasite counts until the end of treatment. Indeed, if they are not free of parasites after seven days of treatment, they will receive rescue treatment, which is the WHO-recommended malaria treatment.\n\nSimilarly, if the number of parasites in their blood increases or they develop malaria-like symptoms during treatment, they will receive rescue treatment.",[31,36],{"label":32,"type":33,"description":22,"interventionNames":34},"Artemisia arm","EXPERIMENTAL",[35],"Drug: Artemisia Annua Leaf",{"label":37,"type":38,"description":22,"interventionNames":39},"Control arm","PLACEBO_COMPARATOR",[40],"Drug: Centaurii herba",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":22},"DRUG","Artemisia Annua Leaf","Dried Artemisia annua leaves will be used to prepare an infusion by adding 5 mg of dried leaves to 1 litre of boiled water. The mixture will be left to stand for 15 minutes, then stirred and strained before being administered to the participant. Participants will receive 1 litre of this infusion (prepared each morning) per day for seven consecutive days. The research team will administer the daily dose in three splits at 8-hour intervals.",[32],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Centaurii herba","The research team will prepare one litre of 'Herba Centaurii' infusion every morning, which will be given to the participants in three splits every 8 hours, under the supervision of the research team for seven consecutive days.",[37],[52],"Centaurium erythrea",[54,58],{"name":55,"affiliation":56,"role":57},"Steffen Borrmann, Prof.","Institut für Tropenmedizin, Universitätsklinikum Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany","STUDY_CHAIR",{"name":59,"affiliation":60,"role":57},"Ayôla Akim Adegnika, Prof.","Centre de Recherches Médicales de Lambaréné",[62],{"name":63,"role":64,"phone":65,"phoneExt":22,"email":66},"Jean Claude Dejon Agobé, MD","CONTACT","0024177989191","jcagobe@cermel.org",[68],{"facility":60,"status":22,"city":69,"state":70,"zip":71,"country":70,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Lambaréné","Gabon","BP: 242","GA",{"type":74,"coordinates":75},"Point",[76,77],10.24055,-0.7001,{"lat":77,"lon":76},[80,82,85,87],{"name":81,"role":64,"phone":65,"phoneExt":22,"email":66},"Jean Claude Dejon Agobé, MD, PhD",{"name":83,"role":64,"phone":65,"phoneExt":22,"email":84},"Christian Chassem Lapue, MD","christian.chassem@cermel.org",{"name":81,"role":86,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":83,"role":88,"phone":22,"phoneExt":22,"email":22},"SUB_INVESTIGATOR",{"type":90,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[92],{"name":93,"class":6},"Institute of Tropical Medicine, University of Tuebingen","100656083","phase-1-artemisia-annua-infusion-for-the-treatment-of-asymptomatic-plasmodium-falciparum-infection-100656083",false,"NCT07819825","Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection","Clinical Assessment of the Safety and Efficacy of Artemisia Annua Infusion Preparation for the Treatment of Asymptomatic Plasmodium Falciparum Infection in Semi-immune Adults in Gabon","ART-CT001","Inclusion Criteria:\n\n* Age: 18 to 45 years\n* Absence of fever (body temperature \\\u003C37.5ºC axillary or \\\u003C38.0°C oral, rectal or tympanic temperature)\n* Asymptomatic P. falciparum infection with parasitemia between 500 and 2,000 asexual P. falciparum parasites per μl of blood\n* Have been living in an endemic area for at least 5 years.\n* Written informed consent from the participant\n* Residence in the vicinity of the study centre\n* Willingness to comply with the follow-up schedule\n\nExclusion Criteria:\n\n* History of fever over the last 72 hours\n* Non-Plasmodium falciparum infection\n* Intake of any antimalarial drug or antibiotic with antimalarial activity within the previous 28 days and\u002For after half-life time\n* Presence of signs and symptoms related by the medical doctor to malaria\n* Known history or evidence of clinically significant medical disorders\n* Severe malnutrition\n* Haemoglobin concentration \\\u003C7 g\u002FdL\n* Known hypersensitivity and contraindications to any study medication\n* Pregnancy or lactation\n* Participation in other interventional studies","ALL","18 Years","45 Years",{"count":106,"type":107},20,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","The goal of this clinical trial is to determine whether Artemisia annua dried leaves, used as an infusion, can treat individuals with malaria parasites but no symptoms. The main question it aims to answer is:\n\nCan Artemisia annua infusion be used to treat malaria?\n\nResearchers will compare those receiving Artemisia annua infusion with those receiving an infusion of Centaurii herba (which has no effect on malaria parasites) to see whether all individuals treated with Artemisia annua infusion are cured, which should not be the case for those receiving Centaurii herba infusion.\n\nParticipants will\n\n* drink Artemisia annua infusion over seven days (three days at our research centre and four days at their home\n* visit the research centre once a week for three weeks after treatment for one month for safety reasons",[113],"Asymptomatic P.Falciparum Malaria",[115,116,117],"Plasmodium falciparum","Artemisia annua","infusion","NOT_YET_RECRUITING","2026-09-09",{"date":121,"type":122},"2026-09-15","ACTUAL",{"date":124,"type":107},"2026-09-01",{"date":126,"type":107},"2027-06",{"name":5,"class":6},1]