In Vivo and In Vitro Efficacy of Artemisinin Combination Therapy

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

Summary

This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ).

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

Details

• Lead Sponsor: Global Emerging Infections Surveillance and Response System
• Collaborators: United States Army Medical Unit - Kenya; Walter Reed Army Institute of Research (WRAIR)
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinine; Artemisinins; Artesunate; Lumefantrine; Mefloquine

Criteria

Inclusion Criteria:

• Adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5 C, or history of fever within 24 hours prior to presentation

• Mono-infection with Plasmodium falciparum

• Baseline parasitemia of 2000 - 200,000 asexual parasites/µl

• Ability to provide informed consent

• Willingness and ability to comply with the study protocol for the duration of the study

• Willingness to remain in the hospital for 3 days

Exclusion Criteria:

• Presence of signs of severe malaria as defined by WHO

• Presence of severe anemia, defined as hemoglobin level below 6 g/dl

• Presence of mixed Plasmodium infection, or mono-infection of non-falciparum Plasmodium

• Inability to take oral medication

• History of allergy or contraindications to the study treatments

• Lactating or pregnant females

• Any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study