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

NCT02043652 | Completed Results

• 1 other identifier: CDC-CGH-6371
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adequate Clearance of Parasites and Symptoms

  Investigators, according to WHO guidelines, will evaluate patients at regular intervals to evaluate symptom and parasitemia clearance.

  28 days

Secondary Outcomes (1)

• Number of Patients Reporting Relapses

  6 months

Study Arms (1)

Chloroquine and primaquine

EXPERIMENTAL

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.

Drug: Chloroquine; Drug: Primaquine

Interventions

Chloroquine DRUG

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.

Chloroquine and primaquine

Primaquine DRUG

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.

Chloroquine and primaquine

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (1)

Hospital do Jurua

Cruzeiro do Sul, Brazil

Location

MeSH Terms

Conditions

Malaria

Interventions

Chloroquine; Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Alexande Macedo de Oliveira
• Organization: CDC

acq7@cdc.gov

404 718 4751

Study Officials

• Alexandre Macedo de Oliveira, MD, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 7, 2018
• Results First Posted: February 7, 2018

Record last verified: 2014-01

Locations

BR (1)