Harmonized AS/MQ Efficacy Study - Thailand

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study is to determine parasitological clearance rates by microscopy for the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum malaria.

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

Details

• Lead Sponsor: Armed Forces Research Institute of Medical Sciences, Thailand
• Collaborators: Global Emerging Infections Surveillance and Response System; Walter Reed Army Institute of Research (WRAIR)
• Treatments: Artemisinins; Artesunate; Mefloquine

Criteria

Inclusion Criteria:

• Thai or non-Thai, otherwise healthy, male or female, aged from 5 years to 65 years inclusive

• Acute uncomplicated P. falciparum malaria monoinfection, confirmed by positive blood smear

• Asexual P. falciparum parasitaemia of 1,000 to 200,000 parasites/µL, confirmed on a thin or thick blood film

• Fever defined as ≥ 38.0°C tympanic temperature (or equivalent) or a history of fever within the last 24 hours

• Willingness to participate in the study as evidenced by written informed consent from the subject or parent/guardian (for children), and by assent (for children)

Exclusion criteria:

• Severe malaria as defined by WHO criteria (reference WHO 2012)

• Inability to eat or drink, inability to tolerate oral antimalarial medication, recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand

• Mixed species asexual stage malaria infection as determined by microscopy

• Recent antimalarial treatment, defined as a clear history of any antimalarial medication taken within the previous 7 days; or a clear history of mefloquine within previous 4 weeks

• History of splenectomy

• Pregnancy or nursing mother

• Known hypersensitivity to artesunate, mefloquine or primaquine

• PI determines that it is in the best interests of the subject not to participate in the trial