Safety and Efficacy Study of IV Artesunate to Treat Malaria

This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).

Inclusion criteria

• Adult male & non-pregnant females, 18-65 years
• Fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever.
• Diagnosis of falciparum malaria, greater than or equal to 200 parasites/uL
• Able to communicate well with the investigator and to comply with the requirements of the entire study.
• Willing to be admitted for the period of drug administration and/or to follow up (return to hospital)
• Provision of the written informed consent to participate as shown by a signature on the informed consent form.

Exclusion criteria

• Administration of any investigational drug in the period 0 to 16 weeks before entry to the study.
• The use of any medication during the period 0 to 14 days (prescribed drugs) or 0 to 5 days (OTC) before entry to the study (including herbal or dietary supplements), except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study.
• Existence of any surgical or medical condition that, in the judgment of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug.
• History of serious adverse reaction or hypersensitivity to study drug or follow on treatment.
• Mixed malaria infection (malaria other than falciparum malaria mono-infection as detected by screening blood smear)
• Severe falciparum malaria (as defined by the WHO; Attachment 1).
• Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study,
• Transfusion of blood within past 30 days.
• Refusal to prevent pregnancy during the 14 days of the trial
• Pregnancy as defined clinically or by a positive urine BHCG at the time of screening, or nursing mothers.
• Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary lab values:

• Creatinine >1.4 x ULN (>2.0 mg/dL)
• Glucose <LLN (65mg/dL)
• AST, ALT >3x ULN (120 U/L)