ACT MALI: Treatment of Malaria Based on Combination Therapies
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ClinicalTrials.gov Identifier: NCT00452907 |
Recruitment Status :
Completed
First Posted : March 28, 2007
Last Update Posted : February 17, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria | Drug: Artesunate Drug: Artesunate + Sulfadoxine-Pyrimethamine Drug: arthemether + lumefantrine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 780 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
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Drug: Artesunate
oad, per os, 3 days of treatment |
Active Comparator: 2
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os
|
Drug: Artesunate + Sulfadoxine-Pyrimethamine
oad, per os |
Active Comparator: 3
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days
|
Drug: arthemether + lumefantrine
bid, per os. Duration of treatment: 3 days |
- Clinical and parasitological cure rate [ Time Frame: at day 28 ]
- Clinical and biological tolerability [ Time Frame: During the study period ]

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Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Body weight > 5kg
- Residence in the investigator site area for the duration of the trial
- Axillary temperature ≥ 37,5°C at Day 0
- Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
Exclusion Criteria:
- Danger signs or signs of severe malaria
- Other severe illnesses
- Allergy to one of the drugs
- Pregnant women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452907
Mali | |
Sanofi-Aventis Administrative Office | |
Bougoula, Mali |
Study Director: | Valérie Lameyre | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00452907 |
Other Study ID Numbers: |
ARTEN_L_00848 |
First Posted: | March 28, 2007 Key Record Dates |
Last Update Posted: | February 17, 2010 |
Last Verified: | February 2010 |
Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Artesunate Lumefantrine Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |