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| Name | Class |
|---|---|
| Malaria Research and Training Center, Bamako, Mali | OTHER |
| Radboud University Medical Center | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
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The purpose of this study is to determine the most efficacious transmission blocking drug regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary endpoint will be a within group comparison between the mean of the pretreatment infectivity (Day 0) and infectivity at 7 days post first dose.
Protocol will be shared on request.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-AQ only | Active Comparator | Subjects will receive sulphadoxine-pyrimethamine (SP) as single dose and administered in combination with amodiaquine (AQ), which will be given once daily for 3 days. |
|
| SP-AQ plus PQ | Experimental | Participants in this arm will receive SP-AQ in combination with a single low dose of primaquine at the World Health Organization (WHO) recommended dose of 0.25 mg/kg. |
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| DP only | Active Comparator | Participants in this arm will be treated with dihydroartemisinin-piperaquine (DP), which will be administered once a day for three days. |
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| DP plus MB | Experimental | Study participants in this arm will receive DP as described above combined with once-daily methylene blue (MB) for 3 days, at 15 mg/kg/day (45 mg/kg total over 3 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulphadoxine-pyrimethamine | Drug | Each Fansidar tablet is scored containing 500mg sulphadoxine and 25 mg pyrimethamine. Doses will be administered by weight. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mosquito infectivity assessed through membrane feeding assays | Infectivity will be measured by oocyst prevalence in dissected mosquitoes. Primary endpoint will be a comparison between mean of pretreatment infectivity (day 0) and infectivity at days 2 and 7 post first dose. | 7 day |
| Measure | Description | Time Frame |
|---|---|---|
| Gametocyte prevalence, density, and sex ratio measured microscopically and by molecular methods. | Outcome measured at baseline and days 1, 2, 3, 7, 14, 28, and 42 post first dose. | 42 days |
| Asexual parasite prevalence and density |
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Inclusion Criteria:
Exclusion 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 |
| Teun Bousema, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malaria Research and Training Centre | Bamako | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29422384 | Derived | Dicko A, Roh ME, Diawara H, Mahamar A, Soumare HM, Lanke K, Bradley J, Sanogo K, Kone DT, Diarra K, Keita S, Issiaka D, Traore SF, McCulloch C, Stone WJR, Hwang J, Muller O, Brown JM, Srinivasan V, Drakeley C, Gosling R, Chen I, Bousema T. Efficacy and safety of primaquine and methylene blue for prevention of Plasmodium falciparum transmission in Mali: a phase 2, single-blind, randomised controlled trial. Lancet Infect Dis. 2018 Jun;18(6):627-639. doi: 10.1016/S1473-3099(18)30044-6. Epub 2018 Feb 6. |
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Data can be shared on request
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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 |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
| D011319 | Primaquine |
| D008751 | Methylene Blue |
| D000655 | Amodiaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Heidelberg University |
| OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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| 0.25 mg/kg primaquine | Drug | Primaquine will be administered in an aqueous solution according to weight-based dosing. |
|
| Dihydroartemisinin-piperaquine | Drug | 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets will be used to administer weight-based doses. |
|
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| Methylene blue | Drug | Methylene blue will be given as minitablets in prepackaged sachets according to weight groups. |
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| Amodiaquine | Drug | Amodiaquine will be administered once daily for 3 days, following weight-based dosing of 150 mg tablets. |
|
Asexual parasitemia will be evaluated by blood smear microscopy and confirmed by more sensitive, molecular methods. Outcome measured at baseline and days 1, 2, 3, 7, 14, 28, and 42 post first dose.
| 42 days |
| Safety measurements including hemoglobin and signs of hemolysis | The major safety endpoint is hemolysis. For this reason, hemoglobin and methemoglobin values will be measured before treatment, at baseline and on days 1, 2, 3, 7, 14, 28, and 42 post first dose. In addition, clinical review (including additional signs of hemolysis) will be assessed based on active and passive follow-up. | 42 days |
| Peak plasma concentration (Cmax) of primaquine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Area under the concentration curve (AUC) of primaquine. | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Elimination half life (t1/2) of primaquine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Peak plasma concentration (Cmax) of methylene blue | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Area under the concentration curve (AUC) of methylene blue | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Elimination half life (t1/2) of methylene blue | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Peak plasma concentration (Cmax) of sulphadoxine-pyrimethamine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Area under the concentration curve (AUC) of sulphadoxine-pyrimethamine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Elimination half-life (t1/2) of sulphadoxine-pyrimethamine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Peak plasma concentration (Cmax) of dihydroartemisinin-piperaquine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Area under the concentration curve (AUC) of dihydroartemisinin-piperaquine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Elimination half-life (t1/2) of dihydroartemisinin-piperaquine | Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose. | 24 hours |
| Identification of cytochrome P450 (CYP) 2D6 and G6PD polymorphisms | CYP2D6 and G6PD genotyping will be performed using Thermo Fisher Scientific OpenArray Technology and Copy Number Variation (CNV) assays on the QuantStudio™ 12K Flex Real-Time PCR System. | 1 hour |
| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |