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| Name | Class |
|---|---|
| Centre national de recherche et de formation sur le paludisme | OTHER_GOV |
| University Medical Center Nijmegen | OTHER |
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The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G6PD deficient 0.25 mg/kg PQ + AL | Experimental | G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine |
|
| G6PD deficient receiving AL only | Active Comparator | G6PD deficient males receiving Artemether-Lumefantrine (AL) combination |
|
| G6PD normal 0.25 mg/kg PQ + AL | Active Comparator | G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine |
|
| G6PD normal 0.4 mg/kg PQ + AL | Active Comparator | G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
|
| G6PD-deficient 0.4 mg/kg PQ + AL | Experimental | G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin concentration relative to baseline value | Haemoglobin concentration relative to baseline value | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gametocyte clearance time | Gametocyte clearance time | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teun Bousema, PhD | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre National de Recherche et de Formation sur le Paludisme | Ouagadougou | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29324864 | Derived | Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018. |
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| Artemether-Lumefantrine (AL) combination |
| Drug |
|
| Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine | Drug |
|
| ID | Term |
|---|---|
| D008288 | Malaria |
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| D011319 | Primaquine |
| ID | Term |
|---|---|
| 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 |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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