Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials

• Status: Active, not recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-center phase II/III clinical investigation of the pharmacokinetics and pharmacodynamics of artemether-lumefantrine and dihydroartemisinin-piperaquine for gametocyte clearance and post-treatment chemoprotection in Zambian children with uncomplicated falciparum malaria.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: Tropical Diseases Research Centre
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Artemisinins; Artenimol; Dihydroartemisinin; Lumefantrine; Piperaquine

Criteria

Inclusion Criteria:

• Weight ≥10 kg

• Any indication for malaria diagnostic testing as determined by a treating provider (e.g., fever or history of fever)

• P. falciparum parasitemia (by microscopy) of any density not meeting criteria for severe malaria

• Ability to swallow oral medication

• Ability and willingness of parents or guardians to comply with study protocol for the duration of the study and to comply with the study follow-up visit schedule

• Residence within hospital catchment area

• Signed informed consent obtained from a legal representative of the participant

Exclusion Criteria:

• Complicated or severe falciparum malaria as defined by WHO criteria

• Hemoglobin concentration < 7 g/dL

• Use of any drug with antimalarial activity within the prior 4 weeks

• History of hypersensitivity reaction or intolerance to AL or DP

• Co-infection with Plasmodium spp. other than P. falciparum as determined by microscopy

• Confirmed or suspected concurrent acute infection other than malaria (e.g. measles, acute lower respiratory tract infection)

• Current therapy with QT interval-prolonging agents

• Family history of sudden cardiac death or personal history of cardiac disease

• Residence outside the study area, or plan to leave the study area

• Residence in foster care or otherwise under government supervision

• Previous enrollment in the study, or enrollment in any other investigational drug trial during the previous 30 days

• Presence of any other condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data