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Lapdap and Coartemether for Uncomplicated Malaria

NCT00118794 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2006-02-01

No results posted yet for this study

Summary

Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.

Conditions

Interventions

DRUG

Chlorproguanil-dapsone (Lapdap)

DRUG

Lumefantrine-artemether (Coartemether )

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • National Malaria Control Programme, The Gambia

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Paul J Milligan, BSc MSc PhD · London School of Hygiene and Tropical Medicine

  • Sam K Dunyo, MD PhD · Medical Research Council

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2005-06-30

Countries

  • The Gambia

Study Locations

More Related Trials

Entities

Diseases
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 NCT00118794 on ClinicalTrials.gov