Treatment of Uncomplicated Malaria in Benin

French Public Scientific and Technological Institution (EPST)

Status: Completed

Conditions: Uncomplicated Malaria

Treatments: Drug: sulfadoxine-pyrimethamine; Drug: amodiaquine-artesunate coformulation; Drug: artemether-lumefantrine

Study type: Interventional

Funder types: Other

Identifiers

NCT00460369

Malariallada

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 6 to 119 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6-119 months old
• fever or history of fever of less than 24 hours
• p falciparum parasitemia > 1000 trophozoïtes/µL
• informed consent signed

Exclusion criteria

• < 5 kg
• danger or severity signs of malaria
• known underlying chronic disease
• Hb < 5g/dL
• adequate malaria treatment taken within 3 days before visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

1

Active Comparator group

Description:

sulfadoxine-pyrimethamine

Treatment:

Drug: sulfadoxine-pyrimethamine

2

Active Comparator group

Description:

artemether-lumefantrine

Treatment:

Drug: artemether-lumefantrine

3

Active Comparator group

Description:

amodiaquine-artesunate coformulation

Treatment:

Drug: amodiaquine-artesunate coformulation