Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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)).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Centers for Disease Control and Prevention; Population Services International; Programme National de Lutte contre le Paludisme (PNLP), Senegal; Université de Thiès, Senegal; US President's Malaria Initiative
• Treatments: Artenimol; Dihydroartemisinin; Piperaquine; Primaquine

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