Malaria Clinical Trial
Official title:
Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
The purpose of this study is to determine whether artemether + lumefantrine is as effective as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria
Background: In the Philippines, close to 11 million people in 65 provinces are at risk for
acquiring malaria infections. It is still one of the ten leading causes of morbidity
nationwide. Each day, roughly 150-200 people fall ill with malaria. In the past 40 years,
the mortality rate stabilized at around 2/100,000 population. Of those people who have
malaria, approximately 1% die per year. Malaria remains one of the major causes of death in
provinces such as Palawan, Isabela, Tawi-tawi, Sulu and Butuan City. Approximately 70% of
all malaria in the Philippines is Plasmodium falciparum with the remaining species being P.
vivax.
Recently the Department of Health (DOH) instituted a change in the national antimalarial
drug guidelines changing from using chloroquine (CQ) and sulfadoxine pyrimethamine (SP)
monotherapy as first and second line drugs, respectively, to a combined chloroquine plus
sulfadoxine-pyrimethamine as first-line treatment, and artemether-lumefantrine (Coartem) as
second line treatment. This change was made due to increasing levels of drug resistance to
the previous first and second-line therapies. In order to have an improved understanding of
the trends of antimalarial drug resistance in the Philippines, the DOH is initiating a
sentinel surveillance system for monitoring of antimalarial drug resistance. Three sites
have been selected to be representative of the country.
Objective: To establish a sentinel surveillance system to assess the efficacy of chloroquine
plus sulfadoxine-pyrimethamine versus artemether + lumefantrine for the treatment of
uncomplicated P. falciparum infections in three areas of the Republic of the Philippines.
Methods: An in vivo antimalarial drug efficacy trial will be conducted in three areas of the
Philippines. Subjects > 6 months of age with parasitologically confirmed, uncomplicated P.
falciparum infections will be recruited. Patients will be treated with single dose SP (25
mg/kg of the sulfadoxine component in a single dose) plus CQ (25 mg/kg over three days) or
artemether + lumefantrine (twice daily) over 3 days. Patients will be randomly assigned one
of the two drugs regimens. Clinical and parasitological parameters will be monitored over a
28-day follow-up period to evaluate drug efficacy. Results from this study will be used to
assist the DOH in assessing their national malaria treatment policy for P. falciparum
malaria.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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