NCT04609098: NECTAR2

Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)

Completed Phase 2 Last updated 9 June 2022

What this trial tests

Phase 2 trial testing Dihydroartemisinin/Piperaquine in Malaria, Falciparum in 80 participants. Completed in 23 December 2020.

Timeline

29 October 2020

Primary endpoint
2 December 2020

23 December 2020

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	29 October 2020
Primary completion	2 December 2020
Estimated completion	23 December 2020
Sites	1 location across Mali

Drugs / interventions tested

• Dihydroartemisinin/Piperaquine
• Tafenoquine 100mg [Arakoda] — full drug profile →

Conditions studied

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

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 12 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 dihydroartemisinin-piperaquine (DP) with and without various low doses of tafenoquine (TQ; 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). Outcome measures will include infectivity to mosquitoes at 2 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density.

Publications & conference data

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

1. Tafenoquine: a toxicity overview.
   Chu CS, Hwang J. · · 2021 · cited 25× · PMID 33306921 · DOI 10.1080/14740338.2021.1859476
2. Single low-dose tafenoquine combined with dihydroartemisinin-piperaquine to reduce Plasmodium falciparum transmission in Ouelessebougou, Mali: a phase 2, single-blind, randomised clinical trial.
   Stone W, Mahamar A, Smit MJ, Sanogo K, et al · · 2022 · cited 18× · PMID 35544095 · DOI 10.1016/s2666-5247(21)00356-6
3. Scoping Review of Antimalarial Drug Candidates in Phase I and II Drug Development.
   Abd-Rahman AN, Zaloumis S, McCarthy JS, Simpson JA, et al · · 2022 · cited 15× · PMID 34843390 · DOI 10.1128/aac.01659-21
4. 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
5. MEFAS, a hybrid of artesunate-mefloquine active against asexual stages of Plasmodium vivax in field isolates, inhibits malaria transmission.
   Penna-Coutinho J, da Silva Araújo M, Campos Aguiar AC, Sá PM, et al · · 2021 · cited 6× · PMID 34637981 · DOI 10.1016/j.ijpddr.2021.09.003
6. 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
7. Recent advances, challenges and updates on the development of therapeutics for malaria.
   Nandal R, Kumar D, Aggarwal N, Kumar V, et al · · 2024 · cited 1× · PMID 38887396 · DOI 10.17179/excli2023-6856