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| Name | Class |
|---|---|
| Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City, Viet Nam | UNKNOWN |
| Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam | OTHER |
| Agency for Science, Technology and Research | OTHER |
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This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.
Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.
Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.
The results of the study will be used to inform malaria treatment guidelines in Viet Nam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroquine | Active Comparator | 25mg base/kg for 3 days |
|
| Dihydroartemisinin/Piperaquine | Active Comparator | Dihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine | Drug |
| ||
| Dihydroartemisinin/Piperaquine |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with adequate response to treatment | Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure. | Day 63 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients classified as Early Treatment Failures | One or more of the following:
| Day 63 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bu Gia Map Health Station | Phước Hòa | Binh Phuoc | Vietnam |
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| Label | URL |
|---|---|
| Oxford University Clinical Research Unit, Viet Nam | View source |
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| ID | Term |
|---|---|
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| C039060 | artenimol |
| C034759 | piperaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Wellcome Trust | OTHER |
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|
| The parasite clearance time | Defined as the time in hours from the first treatment dose to the first of two consecutive parasitemia counts of zero. | Assessed every 6 hours until Day 3, or two consecutive parasite negative slides. |
| Fever clearance time | Defined as the time in hours from the first treatment dose to the start of the first sustained period of 24 hours without fever | Assessed every 6 hours until Day 3, or 24 hours without fever |
| Frequency of adverse and serious adverse events | Day 63 |
| Proportion of patients classified as Late Clinical Failures | One or more of the following:
| Day 63 |
| Proportion of patients classified as Late Parasitological Failures | Presence of parasitaemia on any day between day 7 and day 63 with temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure | Day 63 |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |