Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Background: The World Health Organization recommends that antimalarial treatment policies be
evaluated every few years to check their efficacy. P. vivax malaria is the most common
species in Brazil and cases are concentrated in the Amazon Region in Brazil.
Objectives: Assess the efficacy of chloroquine and primaquine for the treatment of P. vivax
infections in Cruzeiro do Sul, Acre, Brazil.
Methods: An in vivo drug efficacy study will be conducted in Cruzeiro do Sul, Acre State,
Brazil. At least 117 study participants ≥5 years of age with parasitologically confirmed P.
vivax monoinfections will be treated under supervision with chloroquine (CQ) for three days
at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria
Control guidelines. For patients with normal glucose 6 phosphate dehydrogenase activity
levels, investigators will add primaquine at dose of 0.5mg/Kg per day for 7 days. Clinical
and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate
drug efficacy and for a total period of 168 days (6 months) to evaluate chances of
recrudescence, relapse, or reinfection. Blood samples will be taken to measure the CQ levels
in blood on Day 7 and day of failure, if occurring in the initial 28 days of follow up. In
addition, a blood sample will be collected on filter paper on first day and on day of
suspected failure to help differentiate parasite genotypes using techniques based on
polymerase chain reaction. Results from this drug efficacy study will be used to assist the
Brazilian Ministry of Health in assessing their national malaria treatment policy for P.
vivax malaria.