NCT05874869: SMC-DP

Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania

Completed NA Last updated 25 May 2023

What this trial tests

NA trial testing Dihydroartemisinin-piperaquine in Malaria in 13,800 participants. Completed in 30 June 2021.

Timeline

1 July 2020

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Richard Mwaiswelo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	13,800
Start date	1 July 2020
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Tanzania

Drugs / interventions tested

• Dihydroartemisinin-piperaquine

Conditions studied

• Malaria — all drugs for Malaria →
• Chemoprophylaxis — all drugs for Chemoprophylaxis →
• Underfive Children — all drugs for Underfive Children →

Sponsor

Richard Mwaiswelo

Who can join

Adults 3 Months to 59 Months, any sex, with Malaria or Chemoprophylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (ACT). Despite the gained success in the control, malaria has remained a major public health problem, particularly affecting children aged \< 5 years in sub-Saharan Africa. Most of the malaria transmissions occur during the rainy season, a relatively short period. Intervention using antimalarial chemotherapy in children during the transmission season has been shown to prevent malaria-related morbidity and mortality. The World Health Organization has recommended seasonal malaria chemoprevention (SMC) using Sulphadoxine-pyrimethamine (SP) plus amodiaquine (AQ) in children aged 3-59 months in areas with highly seasonal malaria transmission. However, SP-AQ resistance is widespread in Tanzania. Therefore, this study will assess the effectiveness of Dihydroartemisinin-piperaquine (DHA-PQ) as SMC for the control of malaria among children in Tanzania.

Methods: Afebrile children aged 3-59 months from Nanyumbu and Masasi districts in the Mtwara region will be enrolled in an open cluster randomized clinical trial, administered monthly with a full course of DHA-PQ for three or four consecutive months during the high malaria transmission season of the three consecutive years. Three approaches of DHA-PQ SMC administration will be tested; a door-to-door approach using community health workers (CHWs), outreach visits using local health facilities clinicians/nurses, and village health posts using selected CHWs. Study participants will then be followed-up to evaluate the impact of the intervention on all-course of malaria morbidity and mortality; adverse events associated with the intervention; acceptability, adherence, coverage, and cost-effectiveness of the intervention; treatment-seeking behavior; and the risk of rebound after the withdrawal of the intervention. The primary outcome will be a prevalence of clinical malaria defined as the presence of fever (axillary temperature of 37.5 degrees Celsius) or a history of fever in the past 24 hours and the presence of P. falciparum asexual parasitemia at any density.

Findings: The findings will be disseminated through community meetings, seminars, local and international conferences, and publication in international journals.

Impact: The findings from this study will provide information on the effectiveness of DHA-PQ for seasonal prevention of malaria morbidity and mortality in children aged \< 5 years in Tanzania.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dihydroartemisinin-piperaquine effectiveness for seasonal malaria chemoprevention in settings with extended seasonal malaria transmission in Tanzania.
   Mwaiswelo R, Ngasala B, Chaky F, Molteni F, et al · · 2024 · cited 3× · PMID 38273019 · DOI 10.1038/s41598-024-52706-z