Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil

Malaria Clinical Trial

Official title:

Evaluating the Efficacy of Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Cruzeiro do Sul, Acre, Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600767
• Other study ID #: CDC-CGH-2015-204
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: May 17, 2017
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Artemether-lumefantrine combination
This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.

Locations

Country	Name	City	State
Brazil	Hospital do Jurua	Cruzeiro do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Evandro Chagas National Institute of Infectious Disease, Ministry of Health, Brazil, Secretaria Estadual de Saúde do Acre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days