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The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyronaridine-artesunate | Experimental | pyronaridine-artesunate: recommended dose according to body weight, once a day for three days. |
|
| Artemether-lumefantrine | Active Comparator | artemether-lumefantrine: recommended dose according to body weight, twice a day for three days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyronaridine-artesunate | Drug |
|
| |
| Artemether-lumefantrine combination |
| Measure | Description | Time Frame |
|---|---|---|
| PCR-corrected adequate clinical and parasitological response (ACPR) | day 28 after initial dose |
| Measure | Description | Time Frame |
|---|---|---|
| PCR-corrected adequate clinical and parasitological response (ACPR) | day 42 after initial dose | |
| crude adequate clinical and parasitological response (ACPR) | day 28, day 42 after initial dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Sawa, MD, PhD | International Centre of Insect Physiology and Ecology (ICIPE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude's Clinic, ICIPE | Mbita | 30-40305 | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29866116 | Derived | Roth JM, Sawa P, Omweri G, Osoti V, Makio N, Bradley J, Bousema T, Schallig HDFH, Mens PF. Plasmodium falciparum gametocyte dynamics after pyronaridine-artesunate or artemether-lumefantrine treatment. Malar J. 2018 Jun 4;17(1):223. doi: 10.1186/s12936-018-2373-7. | |
| 29764419 | Derived | Roth JM, Sawa P, Makio N, Omweri G, Osoti V, Okach S, Choy F, Schallig HDFH, Mens P. Pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial. Malar J. 2018 May 15;17(1):199. doi: 10.1186/s12936-018-2340-3. |
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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 |
|---|---|
| C000712628 | pyronaridine tetraphosphate, artesunate drug combination |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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| Drug |
|
|
| parasite clearance time |
| up to 7 days after initial dose |
| gametocyte clearance time | up to 7 days after initial dose |
| transmission potential to mosquitos | day 7 after initial dose |
| D000079426 |
| Vector Borne Diseases |
| 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 |