drugset / Trial / NCT00808951

In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso

NCT00808951 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.

Timeline

Start
2008-12
Primary completion
2010-10
Completion
2011-02

Outcome

Met primary endpoint

paper The results showed a significantly higher PCR unadjusted cure rate in ASAQ arm (71.0%) than that in the AL arm (49.8%) on day 42 PMID 31906948 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether-lumefantrine Unknown — —
Subject Artesunate-amodiaquine Unknown 25 mg —
Subject Artesunate-amodiaquine Unknown 50 mg —
Subject Artesunate-amodiaquine Unknown 67.5 mg —
Subject Artesunate-amodiaquine Unknown 100 mg —
Subject Artesunate-amodiaquine Unknown 135 mg —
Subject Artesunate-amodiaquine Unknown 270 mg —

Indications