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

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)).

Conditions

• Malaria,Falciparum
• Malaria

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• L'université de Thiès

  collaborator OTHER

• Programme National de Lutte contre le Paludisme (PNLP), Senegal

  collaborator UNKNOWN

• Population Services International

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• US President's Malaria Initiative

  collaborator UNKNOWN

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Jean Louis Ndiaye, MD PhD · Université de Thiès

• Michelle Hsiang, MD MSc · University of California, San Francisco

• Doudou Séne, MD · Senegal Programme National de Lutte contre le Paludisme (PNLP)

• Katharine Sturm-Ramirez, PhD · US President's Malaria Initiative/CDC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-19

Primary Completion

2022-12-31

Completion

2023-06-30

Countries

• Senegal

Study Locations