Ethiopia Antimalarial in Vivo Efficacy Study 2012

Summary

The investigators hypothesize that the addition of primaquine (PQ) to both artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax infection will result in decreased chance of relapse by about 60%.

The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine the number of recurrent vivax episodes in patients receiving PQ compared to those who don't receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection.

Phase 1 of the study will monitor the clinical, parasitological, and hematological parameters for P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug efficacy. Phase 2 will continue monthly follow-up of these patients for one year to assess frequency of recurring vivax infections. Results from this research study will be used to assist Ethiopia in assessing their current national malaria drug policies.

Conditions

• Plasmodium Vivax Infection

Interventions

DRUG

Artemether-lumefantrine combination

DRUG

Primaquine

DRUG

Chloroquine

Sponsors & Collaborators

• Ethiopian Health and Nutrition Research Institute

  collaborator OTHER

• Federal Minstry of Health of Ethiopia

  collaborator OTHER_GOV

• Columbia University

  collaborator OTHER

• Oromia Regional Health Bureau, Ethiopia

  collaborator UNKNOWN

• United States Agency for International Development (USAID)

  collaborator FED

• Menzies School of Health Research

  collaborator OTHER

• Centers for Disease Control and Prevention

  lead FED

Principal Investigators

• Jimee Hwang, MD MPH · Centers for Disease Control and Prevention

• Tesfay Abreha, MSc, MPH · ICAP-Columbia University, Addis Ababa, Ethiopia

• David Hoos, MD MPH · ICAP-Columbia University, New York, USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• Ethiopia

Study Locations