NCT04049916: NECTAR1

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

Completed Phase 2, PHASE3 Last updated 30 January 2020

What this trial tests

Phase 2, PHASE3 trial testing Pyronaridine Tetraphosphate/Artesunate in Malaria,Falciparum in 100 participants. Completed in 7 January 2020.

Timeline

12 September 2019

Primary endpoint
7 January 2020

7 January 2020

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	12 September 2019
Primary completion	7 January 2020
Estimated completion	7 January 2020
Sites	2 locations across Netherlands, Mali

Drugs / interventions tested

• Pyronaridine Tetraphosphate/Artesunate — full drug profile →
• Dihydroartemisinin/Piperaquine
• Primaquine Diphosphate — full drug profile →

Conditions studied

• Malaria,Falciparum — all drugs for Malaria,Falciparum →

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 5 to 50, any sex, with Malaria,Falciparum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pyronaridine-artesunate or dihydroartemisinin-piperaquine combined with single low-dose primaquine to prevent <i>Plasmodium falciparum</i> malaria transmission in Ouélessébougou, Mali: a four-arm, single-blind, phase 2/3, randomised trial.
   Stone W, Mahamar A, Sanogo K, Sinaba Y, et al · · 2022 · cited 32× · PMID 35028628 · DOI 10.1016/s2666-5247(21)00192-0
2. Persistence of Plasmodium falciparum HRP-2 antigenaemia after artemisinin combination therapy is not associated with gametocytes.
   Oulton T, Mahamar A, Sanogo K, Diallo M, et al · · 2022 · cited 9× · PMID 36474274 · DOI 10.1186/s12936-022-04387-0
3. Genome-wide genetic variation and molecular surveillance of drug resistance in Plasmodium falciparum isolates from asymptomatic individuals in Ouélessébougou, Mali.
   Vanheer LN, Mahamar A, Manko E, Niambele SM, et al · · 2023 · cited 8× · PMID 37308503 · DOI 10.1038/s41598-023-36002-w
4. Preferential transmission of minority and drug-resistant clones in polyclonal infections in Mali.
   Vanheer LN, Manko E, Mahamar A, Phelan J, et al · · 2025 · cited 2× · PMID 40188328 · DOI 10.1186/s12936-025-05298-6
5. The transmission blocking activity of artemisinin-combination, non-artemisinin, and 8-aminoquinoline antimalarial therapies: A pooled analysis of individual participant data.
   Vanheer LN, Ramjith J, Mahamar A, Smit MJ, et al · · 2025 · cited 1× · PMID 40811722 · DOI 10.1371/journal.pmed.1004683
6. A Pan Plasmodium lateral flow recombinase polymerase amplification assay for monitoring malaria parasites in vectors and human populations.
   Higgins M, Kristan M, Collins EL, Messenger LA, et al · · 2024 · cited 1× · PMID 39215071 · DOI 10.1038/s41598-024-71129-4