MedTrace Logo

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

NCT02600767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2017-10-09

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Secretaria Estadual de Saúde do Acre

    collaborator OTHER

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Evandro Chagas National Institute of Infectious Disease

    collaborator OTHER

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Alexandre Macedo de Oliveira, MD · Centers for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-05-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600767 on ClinicalTrials.gov