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.
In: Malaria Journal, Jg. 8 (2009), S. 1-10
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Zugriff:
Background: The efficacy of artemisinin-based combination therapy has already been demonstrated in a number of studies all over the world, and some of them can be regarded as comparably effective. Ease of administration of anti-malarial treatments with shorter courses and fewer tablets may be key determinant of compliance. Methods: Patients with uncomplicated falciparum malaria and over six months of age were recruited in Cameroon, Mali, Rwanda and Sudan. 1,384 patients were randomly assigned to receive artesunate-sulphamethoxypyrazine-pyrimethamine (ASSMP) three-day (once daily for 3 days) regimen (N = 476) or AS-SMP 24-hour (0 h, 12 h, 24 h) regimen (N = 458) or artemetherlumefantrine (AL), the regular 6 doses regimen (N = 450). The primary objective was to demonstrate non-inferiority (using a margin of -6%) of AS-SMP 24 hours or AS-SMP three days versus AL on the PCR-corrected 28-day cure rate. Results: The PCR corrected 28-day cure rate on the intention to treat (ITT) analysis population were: 96.0%(457/476) in the AS-SMP three-day group, 93.7%(429/458) in the AS-SMP 24-hour group and 92.0%(414/450) in the AL group. Likewise, the cure rates on the PP analysis population were high: 99.3%(432/437) in the AS-SMP three-day group, 99.5%(416/419) in the AS-SMP 24-hour group and 99.7(391/394)% in the AL group. Most common drug-related adverse events were gastrointestinal symptoms (such as vomiting and diarrhea) which were slightly higher in the AS-SMP 24-hour group. Conclusion: AS-SMP three days or AS-SMP 24 hours are safe, are as efficacious as AL, and are well tolerated. [ABSTRACT FROM AUTHOR]
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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.
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Autor/in / Beteiligte Person: | Sagara, Issaka ; Rulisa, Stephen ; Mbacham, Wilfred ; Adam, Ishag ; Sissoko, Kourane ; Maiga, Hamma ; Traore, Oumar B. ; Dara, Niawanlou ; Dicko, Yahia T. ; Dicko, Alassane ; Djimdé, Abdoulaye ; Jansen, F Herwig ; Doumbo, Ogobara K. |
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Zeitschrift: | Malaria Journal, Jg. 8 (2009), S. 1-10 |
Veröffentlichung: | 2009 |
Medientyp: | academicJournal |
ISSN: | 1475-2875 (print) |
DOI: | 10.1186/1475-2875-8-63 |
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