NCT04609098

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Full protocol available on request.

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin/Piperaquine	Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine (Eurartesim, Sigma Tau), administered according to weight as per the manufacturer instructions.
DRUG	Tafenoquine 100mg [Arakoda]	Extemporaneous preparation of 1mg/mL Tafenoquine solution, from tablets containing 100mg primaquine (Arakoda, 60degrees pharmaceuticals, DC) dissolved in 100mL water with a non-interacting fruit-flavoured syrup. Solution will be given according to weight as indicated per treatment arm in 5kg bands.

Timeline

• Start date: 2020-10-29
• Primary completion: 2020-12-02
• Completion: 2020-12-23
• First posted: 2020-10-30
• Last updated: 2022-06-09

Locations

1 site across 1 country: Mali