Treatment of Uncomplicated Malaria in Benin

Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460369

Enrollment

240

Registered

2007-04-13

Start date

2007-04-30

Completion date

2007-11-30

Last updated

2008-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated Malaria

Keywords

uncomplicated malaria, children, treatment, effectiveness

Brief 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

Interventions

DRUGsulfadoxine-pyrimethamine

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

DRUGartemether-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

DRUGamodiaquine-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 119 Months

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

Design outcomes

Primary

Measure	Time frame
efficacy	day 28

Secondary

Measure	Time frame
effectiveness comparisons (PCR corrected)	day 14 and day 42
incidence of adverse events	day 42

Countries

Benin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026