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

NCT04609098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-06-09

No results posted yet for this study

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.

Conditions

  • Malaria, Falciparum

Interventions

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.

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Alassane Dicko, PhD, MD · Malaria Research and Training Center, Bamako, Mali

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-29
Primary Completion
2020-12-02
Completion
2020-12-23

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04609098 on ClinicalTrials.gov