Status:
ACTIVE_NOT_RECRUITING
Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Tropical Diseases Research Centre
Conditions:
Uncomplicated Falciparum Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Artemisinin-based combination therapies (ACTs) are the first-line agents for uncomplicated falciparum malaria. Artemether-lumefantrine (AL) is the most widely adopted ACT in sub-Saharan Africa for cas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04009343
Start Date
June 19 2019
End Date
December 1 2026
Last Update
December 17 2025
Active Locations (1)
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1
Tropical Diseases Research Centre
Ndola, Copperbelt, Zambia