Back to resultsArtemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Artemether-lumefantrine combination
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
Eligibility Criteria
Inclusion Criteria:
- >= 5 years
- body weight < 120kg
- documented fever (axillary temperature ≥37.5o C) or history of fever in the previous 48 hours in the absence of other obvious causes of fever, such as pneumonia, middle ear infection, etc.
- monoinfection by P. falciparum with parasitemia between 250 and 200,000 asexual parasites/µl, as determined by swab and thick peripheral blood smear microscopic exam
- patient or parent/caregiver able to comprehend and sign informed consent or permission form
- patients aged 7-17 years able to provide assent, patients aged 5-6 years do not require assent
- willingness to return to the clinic and/or accept home visits for regular check-ups during the 28-day follow-up period
- hemoglobin level ≥8 g/dl
Exclusion Criteria
- presence of malaria danger signs (inability to drink, vomiting (more than twice in the previous 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand up); presence of signs of severe malaria (altered level of consciousness, psychomotor alteration, seizure, torpor and irreversible coma), severe anemia (hematocrit < 15% or clinical signs, hemoglobin <5 g/dl), renal failure (serum creatinine > 3 mg/dl or clinical signs), pulmonary edema, hypoglycemia (blood glucose < 40 mg/dl or clinical signs), shock (systolic blood pressure < 70 mmHg for adults; < 50 mmHg for children), spontaneous hemorrhage/disseminated intravascular coagulation, repeated generalized seizures, acidemia/acidosis (clinical signs), macroscopic hemoglobinuria, and jaundice.
- history of chronic or severe underlying diseases (e.g. heart, renal or liver diseases, HIV/AIDS, tuberculosis, malnourishment)
- history of hypersensitivity to AL
- current pregnancy (history of current pregnancy or positive pregnancy test)
- use of any antimalarial drug in the previous 30 days.
Sites / Locations
- Hospital do Jurua
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Artemether-Lumefantrine
Arm Description
Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.
Outcomes
Primary Outcome Measures
Absence of Malaria Parasites in Blood.
Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.
Secondary Outcome Measures
Full Information
NCT ID
NCT02600767
First Posted
October 22, 2015
Last Updated
May 17, 2017
Sponsor
Centers for Disease Control and Prevention
Collaborators
Secretaria Estadual de Saúde do Acre, Ministry of Health, Brazil, Evandro Chagas National Institute of Infectious Disease
1. Study Identification
Unique Protocol Identification Number
NCT02600767
Brief Title
Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil
Official Title
Evaluating the Efficacy of Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Cruzeiro do Sul, Acre, Brazil
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Secretaria Estadual de Saúde do Acre, Ministry of Health, Brazil, Evandro Chagas National Institute of Infectious Disease
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions. The results of this efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to evaluate the national policy for treatment of malaria caused by P. falciparum.
Detailed Description
This protocol uses the recommended World Health Organization (WHO) protocol for monitoring antimalarial efficacy. Patients with malaria will receive supervised therapy and will be monitored for 28 days to check for treatment response, both clinically and parasitologically. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. Patients will be asked to come back on Days 2, 3, 7, 14, 21 and 28 for clinical evaluation and blood tests using microscopy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions, this will allow us to determine if the recurrent infection was reinfection or failure or recrudescence. Results of this evaluation will guide treatment policies in Brazil.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Evaluation of the efficacy of artemether and lumefantrine for uncomplicated P. falciparum malaria.
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artemether-Lumefantrine
Arm Type
Other
Arm Description
Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination
Other Intervention Name(s)
Coartem
Intervention Description
This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
Primary Outcome Measure Information:
Title
Absence of Malaria Parasites in Blood.
Description
Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>= 5 years
body weight < 120kg
documented fever (axillary temperature ≥37.5o C) or history of fever in the previous 48 hours in the absence of other obvious causes of fever, such as pneumonia, middle ear infection, etc.
monoinfection by P. falciparum with parasitemia between 250 and 200,000 asexual parasites/µl, as determined by swab and thick peripheral blood smear microscopic exam
patient or parent/caregiver able to comprehend and sign informed consent or permission form
patients aged 7-17 years able to provide assent, patients aged 5-6 years do not require assent
willingness to return to the clinic and/or accept home visits for regular check-ups during the 28-day follow-up period
hemoglobin level ≥8 g/dl
Exclusion Criteria
presence of malaria danger signs (inability to drink, vomiting (more than twice in the previous 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand up); presence of signs of severe malaria (altered level of consciousness, psychomotor alteration, seizure, torpor and irreversible coma), severe anemia (hematocrit < 15% or clinical signs, hemoglobin <5 g/dl), renal failure (serum creatinine > 3 mg/dl or clinical signs), pulmonary edema, hypoglycemia (blood glucose < 40 mg/dl or clinical signs), shock (systolic blood pressure < 70 mmHg for adults; < 50 mmHg for children), spontaneous hemorrhage/disseminated intravascular coagulation, repeated generalized seizures, acidemia/acidosis (clinical signs), macroscopic hemoglobinuria, and jaundice.
history of chronic or severe underlying diseases (e.g. heart, renal or liver diseases, HIV/AIDS, tuberculosis, malnourishment)
history of hypersensitivity to AL
current pregnancy (history of current pregnancy or positive pregnancy test)
use of any antimalarial drug in the previous 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Macedo de Oliveira, MD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Jurua
City
Cruzeiro do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil
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