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The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Methylenblue-Amodiaquine | Active Comparator |
| |
| 2-Methylenblue-Artesunate | Active Comparator |
| |
| 3-Artesunate-Amodiaquine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylenblue-Amodiaquine (MB-AQ) | Drug | For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of observed and self-reported non-serious adverse events over the 28 days observation period | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR) | 28 days | |
| Early treatment failure (ETF) rate | 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Mueller, Prof. | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Sante de Nouna | Nouna | Burkina Faso |
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| Methylenblue-Artesunate (MB-AS) | Drug | 3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days |
|
| Artesunate-Amodiaquine (AS-AQ) | Drug | For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS. |
|
| Late clinical failure (LCF) rate at D14 and D28 |
| 28 days |
| Late parasitological failure (LPF) rate at D14 and D28 | 28 days |
| Fever clearance time | 28 days |
| Parasite clearance time | 28 days |
| Change in haematocrit after 2,14 and 28 days compared to baseline | 28 days |
| MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose | 28 days |
| 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 |
|---|---|
| C515299 | amodiaquine, artesunate drug combination |
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