Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission

Summary

The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2 and 7 days after treatment, the duration of infectivity in the artemisinin combination therapy (ACT) only arms, and the production and detectability of histidine rich protein II.

Timeline

Start

2019-09-12

Primary completion

2020-01-07

Completion

2020-01-07

Outcome

Met primary endpoint

paper median percentage reduction in mosquito infection rate 48 h after treatment was 100·0% (IQR 100·0 to 100·0) for individuals treated with pyronaridine-artesunate plus primaquine (n=18; p<0·0001) PMID 35028628 ↗

paper These data support the use of single low-dose primaquine as an effective supplement to dihydroartemisinin-piperaquine and pyronaridine-artesunate for blocking P falciparum transmission. PMID 35028628 ↗

Publications

• Stone W, Mahamar A, Sanogo K, Sinaba Y, Niambele SM, Sacko A, Keita S, Youssouf A, Diallo M, Soumare HM, Kaur H, Lanke K, Ter Heine R, Bradley J, Issiaka D, Diawara H, Traore SF, Bousema T, Drakeley C, Dicko A. Pyronaridine-artesunate or dihydroartemisinin-piperaquine combined with single low-dose primaquine to prevent Plasmodium falciparum malaria transmission in Ouelessebougou, Mali: a four-arm, single-blind, phase 2/3, randomised trial. Lancet Microbe. 2022 Jan;3(1):e41-e51. doi: 10.1016/S2666-5247(21)00192-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ARTENIMOL	Small molecule	40 mg	—
Subject	Artesunate	Small molecule	20 mg	—
Subject	Artesunate	Small molecule	60 mg	—
Subject	Primaquine Diphosphate	Unknown	0.25 mg/kg	Oral
Subject	Pyronaridine Tetraphosphate	Unknown	60 mg	—
Subject	Pyronaridine Tetraphosphate	Unknown	180 mg	—
Comparator	piperaquine	Small molecule	320 mg	—

Indications