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| ID | Type | Description | Link |
|---|---|---|---|
| PA# 04018 |
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| Name | Class |
|---|---|
| Ministry of Health, Malawi | OTHER_GOV |
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulfadoxine-pyrimethamine | Drug | |||
| amodiaquine plus sulfadoxine-pyrimethamine | Drug | |||
| amodiaquine plus artesunate | Drug | |||
| chlorproguanil-dapsone plus artesunate | Drug | |||
| lumefantrine-artemether | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| • Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy) |
| Measure | Description | Time Frame |
|---|---|---|
| • Rate of Adequate clinical and parasitological response 28 days | ||
| • Mean percent change in blood haemoglobin concentration between day 0 and day 28 | ||
| • Incidence of adverse events during the period of observation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel N Bronzan, MD, MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kawale Health Center | Lilongwe | Lilongwe District | Malawi | |||
| Machinga District Hospital |
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| • Rate of Early Treatment Failure (as defined by the WHO in their 2003 standardized protocol for assessing antimalarial drug efficacy) |
| • Rate of Late Clinical Failure (as defined by the WHO) |
| • Rate of Late Parasitologic Failure (as defined by the WHO) |
| • Percent of patients with a decrease in haemoglobin concentration |
| • Percent of patients with a decrease in haemoglobin concentration of ≥ 2g/dl |
| • Prevalence of parasitemia on Day 2 |
| • Prevalence of parasitemia on Day 3 |
| • Gametocyte prevalence on Day 14 |
| • Gametocyte prevalence on Day 28 |
| Liwonde |
| Machinga District |
| Malawi |
| Matiki Health Center | Dwangwa | Nkhotakota District | Malawi |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
| D000655 | Amodiaquine |
| D000077332 | Artesunate |
| C519882 | chloroguanil, dapsone drug combination |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| 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 |
| D000077549 | Artemether |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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