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Primary Objective:
To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.
Secondary Objective:
To compare the clinical safety of the two treatment regimens.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate | Drug | |||
| Amodiaquine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| clinical and parasitological cure on Day 14 | ||
| Secondary: incidence and severity of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie Lameyre | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Yaoundé | Cameroon | ||||
| Sanofi-Aventis |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D000077332 | Artesunate |
| D000655 | Amodiaquine |
| ID | Term |
|---|---|
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
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| Dakar |
| Senegal |
| D000079426 |
| Vector Borne Diseases |
| D009930 |
| Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |