"Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in Bagamoyo District, Tanzania"

• Status: Completed
• Trial end date: 2018-02-17
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial evaluates the advantage of prolonging the therapeutic life span of Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine 0.25mg/kg. The study will have two arms, one that will receive standard treatment of uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the prolonged dose of 6 days together with single low dose primaquine. This approach is expected to provide strategies for malaria control in an era of imminent Plasmodium falciparum resistance.

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

Details

• Lead Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborators: Karolinska Institutet; The University of Western Australia; Uppsala University
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinine; Artemisinins; Lumefantrine; Primaquine

Criteria

Inclusion Criteria:

1. Age more than 1 year and less than 65 years.

2. Weight 10 kg and above;

3. Body temperature ≥37.5°C or history of fever in the last 24 hours;

4. Microscopy determined asexual P. falciparum mono-infection regardless of parasitemia

5. Normal - corrected QT Interval in Baseline ECG of less than 440ms in male and 460ms in females

Exclusion Criteria:

1. Symptoms/signs of severe malaria or danger signs;

2. Pregnancy, Breastfeeding or unwilling to practice birth control during participation in the study.

3. Known allergy to study medications;

4. Hb <8 g/dl;

5. Reported antimalarial intake within last 2 weeks;

6. On regular medication, which may interfere with antimalarial pharmacokinetics and

7. Blood transfusion within last 90 days.