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| ID | Type | Description | Link |
|---|---|---|---|
| DRD140 - S6.2008 | Other Identifier | DAFRA Pharma |
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| Name | Class |
|---|---|
| Dafra Pharma | INDUSTRY |
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The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.
Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In the absence of a vaccine, the major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue to show that schistosome worms have developed reduced susceptibility to Praziquantel. These observations indicate the need for research to monitor the trends in efficacy of praziquantel and the need for research to develop novel antischistosomal drugs. Randomized controlled trials have also shown that Artemisinin derivatives (artesunate, artemether) have antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school children infected with S.mansoni in Rarieda district in western Kenya. To do this we will screen about 1000 school children by examination of stool for schistosome eggs. Eligible children will be randomized to receive either artesunate plus sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction.Our study may provide vital information regarding an alternative treatment for S. mansoni infection in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artesunate+Sulfamethoxypyrazine/pyrimethamine | Experimental |
| |
| Praziquantel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate+Sulfamethoxypyrazine/pyrimethamine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the cure rate between the two treatment arms | after 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the proportion of children excreting schistosoma eggs between the two treatment arms | after 28 days | |
| Compare the amount of eggs produced between the two arms | after 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline N Mwinzi, PhD | Kenya Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KEMRI Centre for Global Health Research | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20705516 | Derived | Obonyo CO, Muok EM, Mwinzi PN. Efficacy of artesunate with sulfalene plus pyrimethamine versus praziquantel for treatment of Schistosoma mansoni in Kenyan children: an open-label randomised controlled trial. Lancet Infect Dis. 2010 Sep;10(9):603-11. doi: 10.1016/S1473-3099(10)70161-4. Epub 2010 Aug 10. |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011739 | Pyrimethamine |
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
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| Praziquantel | Drug |
|
|
| Compare the incidence of clinical and biological adverse events |
| after 28 days |
| D000079426 |
| Vector Borne Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |