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...
Date First Received: April 12, 2007
Last Updated: April 11, 2008
Verified by: Institut de Recherche pour le Developpement, April 2008
Clinical Trial Phase: N/A | Start Date: April 2007
Overall Status: Completed
Estimated Enrollment: 240
Brief Summary
Official Title: “Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study”
Condition Keyword(s):
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: November 2007
Intervention(s) 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
- Time Frame: day 28
Secondary Measures
- effectiveness comparisons (PCR corrected)
- Time Frame: day 14 and day 42
Safety Issue?: No
- Time Frame: day 14 and day 42
- incidence of adverse events
- Time Frame: day 42
Safety Issue?: Yes
- Time Frame: day 42
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 Sponsor Information
Lead Sponsor: Institut de Recherche pour le Developpement
Overall Clinical Trial Officials and Contacts
Jean-François Faucher, MD PhD Principal Investigator Institut de recherche pour le développement UR010
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460369
Study ID Number: Malariallada
ClinicalTrials.gov Identifier: NCT00460369
Health Authority: France: Institutional Ethical Committee
Clinical Trials Authorship and Review
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