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Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

NCT00331136 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-05

Study results available
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Summary

The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.

Conditions

  • Uncomplicated Plasmodium Falciparum Malaria

Interventions

DRUG

Pyronaridine-Artesunate

Once a day for 3 days

Sponsors & Collaborators

  • Shin Poong Pharmaceuticals

    collaborator INDUSTRY

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Michael Ramharter, MD · Albert Schweitzer Hospital, Lambaréné, Gabon

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Gabon

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 NCT00331136 on ClinicalTrials.gov