Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status.

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

Details

• Lead Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborator: Karolinska Institutet
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine; Primaquine

Criteria

Inclusion Criteria:

• Age of 1 year and above and neither pregnant nor breast feeding.

• Weight over 10 kg.

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

• P. falciparum mono-infection.

Exclusion Criteria:

• Evidence of severe illness malaria or danger signs.

• Known allergy to study medications.

• Hemoglobin <8 g/dl.

• Antimalarials taken within last 2 weeks.

• Blood transfusion within last 90 days and evidence of recent use (within 14 days)of or will be taking other drugs known to cause hemolysis in G6PD deficient subjects.