Ethiopia Malaria Therapeutic Efficacy Study

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this stdy, patients aged above 6 months with symptomatic malaria presenting to health centers will be enrolled for treatment with artemether-lumefantrine for P. falciparum infection, and either artemether-lumefantrine or chloroquine for P. vivax infection. Clinical, parasitologic, and hematologic parameters will be monitored for P. falciparum and P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug efficacy. Results from this research study will be used to assist Ethiopia in assessing their current national malaria drug policies.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Columbia University; United States Agency for International Development (USAID)
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Chloroquine; Chloroquine diphosphate; Lumefantrine

Criteria

Inclusion Criteria:

• Slide-confirmed infection with P. falciparum, with parasitemia of 1,000-100,000 asexual forms/ μl or slide confirmed infection with P. vivax with > 250 asexual forms/ μl

• Lives within 20 km of the enrolling health facility

• Weight ≥ 5.0 kg

• Axillary temperature ≥ 37.5º C or history of fever during the previous 24 or 48 hours for P. falciparum and P. vivax infection, respectively

• Patient or caregiver agrees to all blood draws and return visits.

Exclusion Criteria:

• General danger signs or symptoms of severe malaria

• Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values;

• Slide confirmed infection with any other Plasmodium spp. besides falciparum/vivax or mixed plasmodium infection

• Severe anemia, defined as Hg < 5 g/dl

• Known hypersensitivity to any of the drugs being evaluated

• Presence of febrile conditions caused by diseases other than malaria

• Serious or chronic medical condition (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)

• Pregnant or breastfeeding women.

• Children weighing less than 5 kilograms.