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| ID | Type | Description | Link |
|---|---|---|---|
| MRC SCC No. 940 |
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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| National Malaria Control Programme, The Gambia | OTHER_GOV |
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amodiaquine plus artesunate (AQ/AS) | Drug | |||
| Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) | Drug | |||
| Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical failure by day 28 | ||
| Incidence of adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with treatment regimen | ||
| Parasitological failure by day 28 | ||
| Clinical failure by day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam K Dunyo, PhD | Medical Research Council | Principal Investigator |
| Paul J Milligan, PhD | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Council Laboratories | Banjul | City of Banjul | POBOX273 | The Gambia |
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| Parasitological failure rate by day 14 |
| Mean PCV on day 28 |
| Gametocyte carriage rates |
| Transmissibility after treatment |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D000655 | Amodiaquine |
| D000077332 | Artesunate |
| C001205 | fanasil, pyrimethamine drug combination |
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
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