Asaq winthrop

Analyses were performed of P. falciparum positive blood samples from a randomized non-inferiority efficacy trial evaluating ASAQ-FDC [n = 149 (ASAQ Winthrop®, Sanofi-Aventis)] and AL [n = 150 (Coartem®, Novartis)], conducted in 2008–2009 in Saclepea Comprehensive Health Centre in Nimba County, Liberia-a facility at the time supported by Médecins Sans Frontières-Switzerland in collaboration with the Ministry of Health. Children below 5 years of age were enrolled and followed for 42 days. The protocols for the clinical trial was registered with Current Controlled Trials, under the identifier number ISRCTN51688713 [9 (link)]. Blood was collected from the patients on FTA filter papers before treatment and during the follow up.
Parasite molecular markers in pfcrt K76T, pfmdr1 N86Y, Y184F, D1246Y and pfmrp1 I876V and K1466R was assessed in pre-treatment and post-treatment samples, classified according to the 42-day PCR-adjusted outcome. Recrudescences and reinfections were distinguished by stepwise genotyping msp1, msp2 and glurp [9 (link)].

Children meeting inclusion criteria were enrolled and treated on-site with a 3-day regimen of either artesunate–amodiaquine (AS–AQ Winthrop^® Sanofi Aventis), dihydroartemisinin–piperaquine (DHA–PPQ, Eurartesim^® Sigma-Tau) or artemether–lumefantrine (AM–LM, Coartem^® Novartis). All treatments were given under supervision of a nurse and respecting pharmaceutical recommendations (AS–AQ administered once a day with no special recommendations; DHA–PPQ administered once a day at no less than 3 h after the last food intake and no food within 3 h after each dose; AM–LM administered with a glass of milk, the second dose at 7–8 h after the first dose and subsequent doses every 12 h). The allocation of patients to one of the three treatments was randomized. This procedure allowed carrying out inclusions in parallel, and provided a better representativeness of the study population throughout the study period for each of the study treatment.
After admission (day 0), children were followed-up at pre-determined intervals (day 2, 3, 7, 14, 21, 28, 35 and 42) and at any time the care giver judged the child did not feel well. At each visit, both thick and thin blood smears were taken from enrolled patients. Microscopic examination was done under 100× oil immersion magnification. A physician examined the child’s clinical condition during the entire follow-up period.