Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil
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. A total of 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Chloroquine and Primaquine for the Treatment of Plasmodium Vivax Malaria in Cruzeiro do Sul, Acre, Brazil|
- Percentage of patients with adequate clearance of parasites and symptoms [ Time Frame: 28 days ] [ Designated as safety issue: No ]Investigators, according to WHO guidelines, will evaluate patients at regular intervals to evaluate symptom and parasitemia clearance.
- Relapse rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluate the relapse rate, that is reappearance of parasites, for up to 6 months after treatment.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Chlorquine and primaquine
Patients will receive 3-day treatment with chloroquine and 7-day treatment with primaquine in accordance to treatment guidelines in Brazil for P vivax malaria. All patients will receive the same treatment as there is no comparison arm.
Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.Drug: Primaquine
Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02043652
|Contact: Alexandre Macedo de Oliveira, MD||404 718 firstname.lastname@example.org|
|Hospital do Jurua||Not yet recruiting|
|Cruzeiro do Sul, Brazil|
|Contact: Suiane Negreiros, MD email@example.com|
|Principal Investigator: Suiane Negreiros, MD|
|Principal Investigator:||Alexandre Macedo de Oliveira, MD, PhD||Centers for Disease Control and Prevention|