Artemisinin-based Combination Therapy for Malaria in Zambian Children
Artemether-lumefantrine
+ Dihydroartemisinin-piperaquine
Treatment Study
Summary
Study start date: June 19, 2019
Actual date on which the first participant was enrolled.This clinical trial is exploring how two different malaria treatments, artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP), work in clearing malaria parasites and preventing reinfection in young children in Zambia. Malaria, caused by the parasite Plasmodium falciparum, is a significant health concern in sub-Saharan Africa. AL and DP are commonly used to treat malaria, but they work in slightly different ways. AL tends to clear the transmissible form of the malaria parasite, known as gametocytes, more quickly, while DP provides longer protection after treatment. Understanding these differences is important for developing effective malaria treatment policies, especially in areas where the disease is widespread. In the study, children aged 6 to 59 months with confirmed uncomplicated malaria will receive either AL or DP. The treatment will be given under supervision for three days, and the children will stay in the clinic during this period. Researchers will collect samples to measure how quickly the parasites are cleared and how the drugs behave in the body over time. The participants will be monitored for nine weeks to check for any new infections and to assess the effectiveness of the treatments. Genetic tests will help distinguish between new infections and a return of the original infection. The study also investigates how the gut bacteria might affect the way these drugs work. The primary goals are to understand how well each drug clears gametocytes and prevents reinfection, which could help guide future malaria treatment strategies.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.182 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 to 59 Months
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location