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Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

NCT00709969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2008-07-03

No results posted yet for this study

Summary

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Artemether-lumefantrine

20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Avenue Appia 20

    collaborator UNKNOWN

  • CH - 1211 Geneva 27

    collaborator UNKNOWN

  • Switzerland

    collaborator UNKNOWN

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Novartis · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2003-02-28

Countries

  • Kenya
  • Nigeria
  • Tanzania

Study Locations

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Entities

Companies

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 NCT00709969 on ClinicalTrials.gov