Ethiopia Antimalarial in Vivo Efficacy Study 2012

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Columbia University; Ethiopian Health and Nutrition Research Institute; Federal Ministry of Health, Ethiopia; Federal Minstry of Health of Ethiopia; Menzies School of Health Research; Oromia Regional Health Bureau, Ethiopia; United States Agency for International Development (USAID)
• Treatments: Antimalarials; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Chloroquine; Chloroquine diphosphate; Lumefantrine; Primaquine

Criteria

Inclusion Criteria:

• Slide-confirmed infection with P. vivax

• Age > 1 year

• 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 48 hours

• Patient or caregiver agrees to all finger pricks and return visits.

Exclusion Criteria:

• General danger signs or symptoms of severe malaria (see Annex II)

• 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 species. besides P. vivax mono-infection

• Acute anemia, defined as Hg < 8 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 by history (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)

• Pregnant or breastfeeding women.

• History or hemolysis or severe anemia

• Regular medication, which may interfere with antimalarial pharmacokinetics