protocolSection identificationModule nctId: NCT06347471, orgStudyIdInfo id: SBS-2023-477, briefTitle: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy, acronym: SPARTAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Infectious Diseases Research Collaboration, Uganda, class: OTHER, collaborators name: London School of Hygiene and Tropical Medicine, collaborators name: Radboud University Medical Center, descriptionModule briefSummary: A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment., conditionsModule conditions: Falciparum; Malaria, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Artemether-lumefantrine, interventions name: Dihydroartemisinin-Piperaquine, outcomesModule primaryOutcomes measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline., secondaryOutcomes measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline, secondaryOutcomes measure: Mean oocyst intensity (in all/all infected mosquitoes), secondaryOutcomes measure: Male and female gametocyte sex ratio (proportion male), secondaryOutcomes measure: Gametocyte circulation time, secondaryOutcomes measure: Gametocyte area under the curve, secondaryOutcomes measure: Asexual parasite prevalence, secondaryOutcomes measure: Asexual parasite density, secondaryOutcomes measure: Total parasite prevalence, secondaryOutcomes measure: Total parasite density, secondaryOutcomes measure: The density of ΔPfK13 vs wild type genotypes, secondaryOutcomes measure: The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Ambrosoli Memorial Hospital, city: Kalongo, state: Agago District, country: Uganda, contacts name: Maurice Akao, MBChB, role: CONTACT, locations facility: Patongo Health Facility IV, city: Patongo, state: Agago District, country: Uganda, contacts name: MD, role: CONTACT, geoPoint lat: 2.74472, lon: 33.32417, hasResults: False