Brief Summary

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

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

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: November 2007

Interventions Used in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • sulfadoxine-pyrimethamine
• Active Comparator: 2
  • artemether-lumefantrine
• Active Comparator: 3
  • amodiaquine-artesunate coformulation

Outcome Measures for this Clinical Trial

Primary Measures

• efficacy
  • Time Frame: day 28
    Safety Issue?: No

Secondary Measures

• effectiveness comparisons (PCR corrected)
  • Time Frame: day 14 and day 42
    Safety Issue?: No
• incidence of adverse events
  • Time Frame: day 42
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 119 Months

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Institut de Recherche pour le Developpement
• Provider of Information About this Clinical Study
  • Faucher, Institut de Recherche pour le Développement
• Overall Official(s)
  • Jean-François Faucher, MD PhD, Principal Investigator, Institut de recherche pour le développement UR010
  • Philippe Deloron, MD PhD, Study Director, Institut de Recherche pour le Développement UR010