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Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.
Secondary objectives:
For the first attack: To compare the two groups of treatment in terms of:
For the repeated attacks: To compare the two groups of treatment in terms of:
During the total follow-up of the cohort: To compare the two groups of treatment in term of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) | Drug | Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg |
| Measure | Description | Time Frame |
|---|---|---|
| PCR corrected and uncorrected clinical and parasitological cure rate | at D28 and for the first attack |
| Measure | Description | Time Frame |
|---|---|---|
| PCR corrected and uncorrected clinical and parasitological cure rate | at D28 and for the next attacks | |
| Fever and parasitological clearance | first attack | |
| Proportion of afebrile patients and proportion of patients without parasites |
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Lists of Inclusion and Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Lemeyre | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Dakar | Senegal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21838909 | Derived | Ndiaye JL, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, Ndiaye I, Barry A, Cisse B, Lameyre V, Gaye O. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011 Aug 12;10:237. doi: 10.1186/1475-2875-10-237. |
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| Coartem® (arthemether+ lumefantrine) | Drug | Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days |
|
| at D3 for the following attacks |
| Clinical tolerability (incidence and intensity of recorded AE) | during the study period |
| Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) | during the study period |
| Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years) | at the time of the first attack |
| Assessment and evolution of hearing function in patients groupe aged >=12 years | during the study period |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D000655 | Amodiaquine |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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