Skip to main content
OpenTrials
Completed

NCT Number: NCT00460369

Treatment of Uncomplicated Malaria in Benin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uncomplicated Malaria

Age range

6 month–119 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de santé

Allada, Benin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfadoxine-Pyrimethamine

Drug

tablets 1,25/25 mg

1 tablet per 20 kg of body weight Single drug intake

Other names: Fansidar

Artemether-lumefantrine

Drug

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

Other names: coartem

amodiaquine-artesunate coformulation

Drug

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

Other names: coarsucam

Primary outcomes

  1. efficacy

    Time frame: day 28

Secondary outcomes

  1. effectiveness comparisons (PCR corrected)

    Time frame: day 14 and day 42

  2. incidence of adverse events

    Time frame: day 42

Sponsors and collaborators

Lead sponsor

Institut de Recherche pour le Developpement

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 13, 2007
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.