Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective E… (NCT04009343) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials
Zambia182 participantsStarted 2019-06-19
Plain-language 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.
Who can participate
Age range6 Months – 59 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Treatment outcome
Timeframe: 9 weeks
2
Area-under-the-curve (AUC) of the gametocyte concentration-time curve
Timeframe: 72 hours
3
Incidence of reinfection during the 9-week follow-up period
Timeframe: 9 weeks
Trial details
NCT IDNCT04009343
SponsorJohns Hopkins Bloomberg School of Public Health