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Clinical trial

Mass Drug Administration With Dihydroartemisinin-piperaquine and Primaquine to Reduce Malaria in a Moderate-low Transmission Setting in Senegal: A Cluster Randomized Controlled Trial

ID
Name
20-29886
Description
This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).
Trial arms
Trial start
2021-06-19
Estimated PCD
2022-12-31
Trial end
2023-06-30
Status
Completed
Treatment
Dihydroartemisinin-piperaquine
DHA-PPQ will be given over the course of three consecutive days using 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets. DHA-PPQ will be administered via age-based dosing. All three doses will be directly observed and given orally with water and without food.
Arms:
MDA with DHA-PPQ + SLD-PQ
Other names:
Duo-Cotecxin
Primaquine
Primaquine will be given once with the first dose of DHA-PPQ. Primaquine will be administered in an aqueous solution according to age-based dosing guidelines.
Arms:
MDA with DHA-PPQ + SLD-PQ
Size
10715
Primary endpoint
Difference in village-level confirmed incidence of malaria
one year post-MDA
Eligibility criteria
Inclusion Criteria: * Age ≥3 months * Willingness to comply with trial procedures and written informed consent to be obtained at the beginning of the study Exclusion Criteria: * Severe illness or self-reported chronic illness (e.g., HIV, tuberculosis, heart/liver/kidney disease, and severe malnutrition) * Known hypersensitivity to study drug Additional exclusion criteria for DHA-PPQ: * First trimester pregnancy assessed by history and/or urine pregnancy testing * Concurrent artemisinin-based combination therapy (ACT) use * Taking drugs that influence cardiac function or prolong QTc interval Additional exclusion criteria for PQ: * Pregnancy (any trimester) or currently breastfeeding an infant \<6 months of age assessed by history and/or urine pregnancy testing * \<2 years of age
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a two-arm cluster randomized controlled trial. A total of 60 villages will be randomized to receive the intervention (three rounds of MDA with DHA-PPQ + SLD-PQ) or control (standard malaria control measures, including SMC) at a ratio of 1:1', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10715, 'type': 'ACTUAL'}}
Updated at
2023-08-14

1 organization

2 products

1 indication

Organization
University of California, San Francisco
Product
Dihydroartemisinin-piperaquine
Indication
Malaria
Product
Primaquine