Safety and Efficacy Study of IV Artesunate to Treat Malaria
Condition: Malaria
MeSH terms: Malaria
Intervention: Artesunate; Malarone
Intervention description: Intravenous Artesunate (2.4 mg/kg) once a day for three days; (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
Intervention MeSH terms: Artesunate; Atovaquone; Proguanil; Quinidine; Atovaquone, proguanil drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Uncomplicated Malaria; GMP artesunate

Summary:

      The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by
      individuals with uncomplicated malaria infection and to determine how fast it eliminates
      malaria infection from the body.
    

Eligibility criteria:

        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)