Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in
Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to
an imminent need for the government of Malawi to identify a new first-line therapy for
uncomplicated malaria and to implement that new therapy as policy. This protocol is the
second of two protocols whose combined purpose is to provide efficacy and side effect data on
four antimalarial drug combinations that are candidates for the next first-line therapy for
uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and
tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus
artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone
plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years
and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the
therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry
in 1995 because of a perceived association with abdominal pain. Although no studies were
conducted to substantiate this, consensus among clinicians was that patients were refusing
amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was
removed from the registry. Results from this study, along with the efficacy data from the
sister protocol in children under five years of age, will help guide the National Malaria
Control Program of Malawi in selecting their next first-line antimalarial therapy.