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Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau

NCT00426439 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-01-04

No results posted yet for this study

Summary

This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau. The genetic basis of the parasites for developing resistance will be examined. Children coming to one of the Health Centres with symptoms of malaria and a positive malaria test will be included. The children will be followed weekly until day 70. In case of reappearance of parasites the child will be re-treated with the opposite study drug.

Conditions

  • Malaria, Falciparum

Interventions

DRUG

Chloroquine

Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.

DRUG

Artemether-lumefantrine (Coartem)

Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, \< 34 kg: 4 tablets.

Sponsors & Collaborators

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Guinea-Bissau

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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 NCT00426439 on ClinicalTrials.gov