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Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)

NCT02174900 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-02-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.

Conditions

Interventions

DRUG

Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine

DRUG

Artemether-Lumefantrine (AL) combination

DRUG

Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

Sponsors & Collaborators

  • Centre national de recherche et de formation sur le paludisme

    collaborator OTHER_GOV

  • University Medical Center Nijmegen

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Teun Bousema, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

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 NCT02174900 on ClinicalTrials.gov