Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Treatments: Chloroquine; Chloroquine diphosphate; Primaquine

Criteria

Inclusion Criteria:

• 1. Age ≥5 years; Body weight <120 kg ; documented fever (axillary temperature >37.5o C) or history of fever during the previous 48 hours in the absence of another obvious cause of fever, such as pneumonia, otitis media, etc ; Monoinfection with P. vivax with parasitemia between 250 and 100,000 asexual parasites/µl as determined by microscopic examination of thick and thin peripheral blood smears ; Informed consent from the patient or parent/guardian (for those <18 years), assent from child (ages 7 to 17 years inclusive), patients 5 through 6 years old will not need an assent ; Willingness on the part of the patient to return to the clinic and/or receive home visits for regular check-ups during the 6-month (168 days) follow-up period ; Place of residence within 30-45 minutes of study site.

Exclusion Criteria:

• 1. Presence of malaria danger signs ; presence of other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, tuberculosis, malnutrition) ; History of hypersensitivity reactions to any of the drugs being tested ; Current pregnancy (either self-reported being pregnant at enrollment or a positive urine pregnancy test at time of enrollment), previous pregnancy is not an exclusion criteria