Effectiveness of artesunate-amodiaquine vs. artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Nanoro, Burkina Faso: a non-inferiority randomised trial.
OBJECTIVE
Artemisinin-based combination therapies (ACTs) are essential for the effective control of falciparum malaria in endemic countries. However, in most countries, such choice has been carried out without knowing their effectiveness when deployed in real-life conditions, that is, when treatment is not directly observed. We report here the results of a study assessing the effectiveness of the two ACTs currently recommended in Burkina Faso for the treatment of uncomplicated malaria, that is, artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ).


METHODS
Between September 2008 and January 2010, 340 children were randomised to one of the two study arms and followed up for 42 days. Treatment was administered according to routine practices, that is, the first dose was given by study nurses who explained to the parent/guardian how to administer the other doses at home during the following 2 days.


RESULTS
The results showed a significantly higher unadjusted adequate clinical and parasitological response in the ASAQ (58.4%) than in the AL arm (46.1%) at day 28 but these trends were similar after correction with PCR data (ASAQ (89.7%) and AL (89.8%)). New infections started to appear after day 14, first in the AL and then in the ASAQ arm but at day 42 day of follow-up we observed no difference in the occurrence of recrudescent infection.


CONCLUSIONS
Despite a lower cure rate than those reported in efficacy studies in which the treatment administration was directly observed, both AL and ASAQ can still be used for the treatment of uncomplicated malaria in Burkina Faso.
Unité de Recherche sur le Paludisme et les Maladies Tropicales Négligées, Centre Muraz, Bobo-Dioulasso, Burkina Faso; Institut de Recherche en Sciences de la Santé, Direction Régionale, Bobo-Dioulasso, Burkina Faso; Clinical Research Unit of Nanoro, Nanoro, Burkina Faso.
Halidou
H
Tinto
Salou
S
Diallo
Issaka
I
Zongo
Issa
I
Guiraud
Innocent
I
Valea
Adama
A
Kazienga
Hervé
H
Kpoda
Hermann
H
Sorgho
Jean-Bosco
JB
Ouédraogo
Tinga Robert
TR
Guiguemdé
Umberto
U
D'Alessandro
D000655:Amodiaquine / Q000494:pharmacology / Q000627:therapeutic use*; D000962:Antimalarials / Q000494:pharmacology / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000494:pharmacology / Q000627:therapeutic use*; D002050:Burkina Faso; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D053208:Kaplan-Meier Estimate; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D013810:Therapeutic Equivalency
D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine
Burkina Faso; artemisinin-based combination therapies; effectiveness; uncomplicated malaria