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| Name | Class |
|---|---|
| Medicines for Malaria Venture | OTHER |
The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later.
The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artesunate + Amodiaquine | Experimental | Oral fixed combination of artesunate (AS) and amodiaquine (AQ) Once daily, dose according to age Infants 2-11 months: AS 25/AQ 67,5 mg (3 tablets/ blister) Toddlers 1-5 years: AS 50/AQ 135 mg (3 tablets/ blister) Children: 6-13 years: AS 100/AQ 270 mg (3 tablets/ blister) Adults: >= 14 years: AS 100/AQ 270 mg (6 tablets/ blister) 3 day-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate + Amodiaquine | Drug | Artesunate + Amodiaquine fixed dose combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR) | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without fever | Day 3 | |
| Number of patients without parasite | Day 3 | |
| Number of gametocytes |
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Inclusion 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 |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 1 | Agboville District | Côte d’Ivoire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29362685 | Derived | Assi SB, Nguessan AF, Aba YT, Toure AO, Menan H, Yavo JC, San KM, Bissagnene E, Duparc S, Lameyre V, Tanoh MA. Sustained Effectiveness of a Fixed-Dose Combination of Artesunate and Amodiaquine in 480 Patients with Uncomplicated Plasmodium falciparum Malaria in Cote d'Ivoire. Malar Res Treat. 2017;2017:3958765. doi: 10.1155/2017/3958765. Epub 2017 Dec 7. |
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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 |
|---|---|
| C515299 | amodiaquine, artesunate drug combination |
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| Day 3, Day 7, Day 14, Day 21 and Day 28 |
| Evolution of in vitro resistance rate | Day 3, Day 7, Day 14, Day 21 and Day 28 |
| D000079426 |
| Vector Borne Diseases |