Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil
Status:
Completed
Trial end date:
2019-03-12
Target enrollment:
Participant gender:
Summary
We plan to assess the efficacy of 3 different regimens of chloroquine and primaquine for the
treatment of P. vivax infections in Cruzeiro do Sul, Acre, Brazil. Patients will be divided
in 3 different groups: treatment with regular dose of primaquine (0.5 mg/kg per day for 7
days) with directly observed therapy; regular dose of primaquine without directly observed
therapy; and increased total dose of primaquine (0.5 mg/kg per day for14 days) with directly
observed therapy. All patients will receive chloroquine (CQ) for three days at a daily dose
of approximately 25 mg/Kg in accordance with the Brazilian National Malaria Control
guidelines. 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 (24 weeks) to evaluate
chances of recrudescence, relapse, or reinfection. 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.
Phase:
N/A
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
Evandro Chagas National Institute of Infectious Disease Ministry of Health, Brazil