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Low Dose Primaquine for Clearance of Gametocytes

NCT01935882 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2015-09-02

No results posted yet for this study

Summary

Primaquine (PQ) is currently the only available drug that can clear mature transmission stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist after artemisinin-combination therapy. However, there are safety concerns about the use of PQ at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD deficient individuals; this side-effect is dose dependent. There are indications that a lower dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for gametocyte clearance is currently unknown. Recently, the World Health Organization changed their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and what the lowest efficacious dose is.

In the current study we aim to identify the lowest efficacious dose of PQ in individuals with normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will be randomized to treatment with artemether-lumefantrine alone or in combination with low doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy will be determined based on gametocyte carriage during follow-up, measured by molecular methods. For a subset of participants with patent gametocytes, primaquine effect on infectivity to mosquitoes will be assessed by membrane feeding assays

Conditions

  • Malaria
  • Asymptomatic Malaria
  • Plasmodium Falciparum

Interventions

DRUG

Artemether-lumefantrine combination

DRUG

Artemether-Lumefantrine with a single dose of 0.25mg/kg primaquine

DRUG

Artemether-Lumefantrine with a single dose of 0.4mg/kg primaquine

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Centre national de recherche et de formation sur le paludisme

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Alfred Tiono, PhD, MD · Centre national de recherche et de formation sur le paludisme

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

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 NCT01935882 on ClinicalTrials.gov