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| Name | Class |
|---|---|
| Malaria Research and Training Center, Bamako, Mali | OTHER |
| Shoklo Malaria Research Unit | OTHER |
| Mahidol Oxford Tropical Medicine Research Unit | OTHER |
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The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dihydroartemisinin-piperaquine only | Active Comparator | dihydroartemisinin -piperaquine (DP) only |
|
| DP and 0.125 mg/kg primaquine | Experimental | DP and single dose oral 0.125 mg/kg primaquine |
|
| DP and 0.5 mg/kg primaquine | Experimental | DP and single dose oral 0.5 mg/kg primaquine |
|
| DP and 0.25 mg/kg primaquine | Experimental | DP and a single dose oral 0.25 mg/kg primaquine |
|
| DP and 0.0625 mg/kg primaquine | Experimental | DP and a single dose oral 0.0625 mg/kg primaquine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dihydroartemisinin-piperaquine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| mosquito infectivity assessed through membrane feeding | Baseline, Days 1, 2, 7 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| gametocyte prevalence and density | Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28 | 28 days |
| primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite | Hours 1, 2, 3, 4, 6, 8, 12, 24 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Gosling, MD, PhD | University of California, San Francisco | Principal Investigator |
| Alassane Dicko, MD | Malaria Research and Training Centre | Principal Investigator |
| François Nosten, MD | Shoklo Malaria Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malaria Research and Training Centre | Bamako | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21951597 | Background | Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26. | |
| 17254503 | Background | Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4. |
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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 |
|---|---|
| D011319 | Primaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Bill and Melinda Gates Foundation |
| OTHER |
| Wellcome Trust | OTHER |
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| 0.125 mg/kg Primaquine | Drug |
|
| 0.5 mg/kg Primaquine | Drug |
|
| 0.25 mg/kg Primaquine | Drug |
|
| 0.0625 mg/kg Primaquine | Drug |
|
| 24 hours |
| asexual parasite prevalence and density | Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28 | 28 days |
| safety measurements including hemoglobin and signs of hemolysis | Baseline, Days 1, 2, 3, 7, 14, 28 | 28 days |
| Background | WHO (2011) World Malaria Report 2011. Geneva: World Health Organization. |
| Background | WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization |
| 18074034 | Background | El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311. |
| 20194698 | Background | Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1. |
| 26906747 | Derived | Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20. |
| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |