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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Centers for Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT02043652
First received: January 16, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Malaria
Drug: Chloroquine
Drug: Primaquine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 117
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)
Arms Assigned Interventions
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.
Drug: Chloroquine
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043652

Contacts
Contact: Alexandre Macedo de Oliveira, MD 404 718 4751 acq7@cdc.gov

Locations
Brazil
Hospital do Jurua Not yet recruiting
Cruzeiro do Sul, Brazil
Contact: Suiane Negreiros, MD       omsvalle@hotmail.com   
Principal Investigator: Suiane Negreiros, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Alexandre Macedo de Oliveira, MD, PhD Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02043652     History of Changes
Other Study ID Numbers: CDC-CGH-6371
Study First Received: January 16, 2014
Last Updated: January 22, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Primaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014