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Treatment of Uncomplicated Malaria in Benin

NCT00460369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2008-04-14

No results posted yet for this study

Summary

Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.

The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.

Expected total enrollment: 225 patients

Study start: April 2007; expected completion: December 2007

Conditions

  • Uncomplicated Malaria

Interventions

DRUG

sulfadoxine-pyrimethamine

tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake

DRUG

artemether-lumefantrine

tablets 20/120 mg * 1 tablet twice daily for 3 days below 15 kg of bodyweight * 2 tablets twice daily for 3 days below 24 kg of bodyweight * 3 tablets twice daily for 3 days below 35 kg of bodyweight

DRUG

amodiaquine-artesunate coformulation

one 25mg/67,5mg tablet, once daily for 3 days below 9 kg one 50/135mg tablet, once daily for 3 days below 18 kg

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Jean-François Faucher, MD PhD · Institut de recherche pour le développement UR010

  • Philippe Deloron, MD PhD · Institut de Recherche pour le Développement UR010

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
119 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Benin

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 NCT00460369 on ClinicalTrials.gov