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The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-Arinate FDC | Drug | |||
| Coartem | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| PCR corrected Adequate Clinical and Parasitological Response | on day 28 (follow-up period) | |
| Early treatment failure | between day 0 and day 3 | |
| Late clinical failure | between day 4 and day 28 | |
| Late parasitological failure | between day 7 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Parasitic clearance | 28 day follow-up period | |
| Fever clearance | 28 day follow-up period | |
| Parasitological re-infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issaka Sagara, Dr | University of Bamako, Mali | Principal Investigator |
| Wilfred F Mbacham, Dr | University Yaoundé, Cameroon | Principal Investigator |
| Ishag A Adam, Dr | University of Khartoum, Sudan | Principal Investigator |
| Stephen Rulisa, Dr | Kigali Central University Hospital, Rwanda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cameroon Baptist Convention Clinic of Biyem-Assi | Yaoundé | Cameroon | ||||
| Health centres of Samako, Kolle and Bancoumane |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19366448 | Derived | Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63. |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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| 28 day follow-up period |
| Gametocyte carriage | 28 day follow-up period |
| Safety - Adverse events | 28 day follow-up period |
| Haemoglobin levels | 28 day follow-up period |
| Clinical and biological tolerance (Haemogram + Lever tests) | 28 day follow-up period |
| Bamako |
| Mali |
| Health centres Rwamagana and Muhima | Kigali | Rwanda |
| Alhara Alola Health centre | New Halfa | Sudan |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007287 |
| Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |