OBJECTIVE: To test the hypothesis that artesunate plus amodiaquine (ASAQ) is as effective as artemether-lumefantrine (AL) in the treatment of acute uncomplicated malaria in Nigerian children. METHODS: In an open label, randomized controlled clinical trial, children aged 6 months to 10 years were randomized to receive artesunate (4 mg/kg daily) plus amodiaquine (10 mg/kg daily) or AL (5-14 kg, one tablet; 15-24 kg, two tablets and 25-34 kg, three tablets twice daily). Both drug regimens were given for 3 days and follow-up was for 28 days. RESULTS: A total of 132 children (66 in each group) were randomized to receive either ASAQ or AL. Day 28 cure rates in the per protocol (PP) population were 93% for ASAQ and 95% for AL (OR = 0.71, 95% CI = 0.12-3.99, rho = 0.66). Using Kaplan-Meier product-limit estimates of failure, the median survival time for ASAQ was 21 days and for AL 28 days (P = 0.294). PCR corrected day 28 cure rate for PP populations were 98.4% for ASAQ and 100% for AL. Both drugs were well-tolerated. CONCLUSION:ASAQ is as effective as AL and both combinations were efficacious and safe.
RCT Entities:
OBJECTIVE: To test the hypothesis that artesunate plus amodiaquine (ASAQ) is as effective as artemether-lumefantrine (AL) in the treatment of acute uncomplicated malaria in Nigerian children. METHODS: In an open label, randomized controlled clinical trial, children aged 6 months to 10 years were randomized to receive artesunate (4 mg/kg daily) plus amodiaquine (10 mg/kg daily) or AL (5-14 kg, one tablet; 15-24 kg, two tablets and 25-34 kg, three tablets twice daily). Both drug regimens were given for 3 days and follow-up was for 28 days. RESULTS: A total of 132 children (66 in each group) were randomized to receive either ASAQ or AL. Day 28 cure rates in the per protocol (PP) population were 93% for ASAQ and 95% for AL (OR = 0.71, 95% CI = 0.12-3.99, rho = 0.66). Using Kaplan-Meier product-limit estimates of failure, the median survival time for ASAQ was 21 days and for AL 28 days (P = 0.294). PCR corrected day 28 cure rate for PP populations were 98.4% for ASAQ and 100% for AL. Both drugs were well-tolerated. CONCLUSION:ASAQ is as effective as AL and both combinations were efficacious and safe.
Authors: C W Sawadogo; M Amood Al-Kamarany; H M Al-Mekhlafi; M Elkarbane; A H Al-Adhroey; Y Cherrah; A Bouklouze Journal: Ann Trop Med Parasitol Date: 2011-09
Authors: Zul Premji; Rich E Umeh; Seth Owusu-Agyei; Fabian Esamai; Emmanuel U Ezedinachi; Stephen Oguche; Steffen Borrmann; Akintunde Sowunmi; Stephan Duparc; Paula L Kirby; Allan Pamba; Lynda Kellam; Robert Guiguemdé; Brian Greenwood; Stephen A Ward; Peter A Winstanley Journal: PLoS One Date: 2009-08-19 Impact factor: 3.240
Authors: Adoke Yeka; Ruth Kigozi; Melissa D Conrad; Myers Lugemwa; Peter Okui; Charles Katureebe; Kassahun Belay; Bryan K Kapella; Michelle A Chang; Moses R Kamya; Sarah G Staedke; Grant Dorsey; Philip J Rosenthal Journal: J Infect Dis Date: 2015-11-23 Impact factor: 5.226