Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria
Condition: Malaria; Severe Malaria
MeSH terms: Malaria
Intervention: Actidose Aqua; Artesunate; Amodiaquine
Intervention description: Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the United States in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.; Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO; Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions.
Intervention MeSH terms: Artesunate; Amodiaquine; Charcoal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Parasite Clearance Rate; Parasite Half Life; Actidose Aqua; Severe Malaria

Summary:

      Background:

      - Malaria is caused by small parasites carried by some mosquitoes. People can get malaria if
      an infected mosquito bites them. Malaria destroys red blood cells. Most malaria is mild, but
      some children develop severe malaria, which kills about 660,000 people annually. About 9 in
      10 who die of malaria are Sub-Saharan African children, most under 5 years old. Scientists
      can save many lives if they find out how to prevent or relieve severe malaria.

      Objective:

      - To know if a common medicine called activated charcoal can reduce severe malaria symptoms.

      Eligibility:

      - Children 2 to 11 years old with mild malaria who live in Kenieroba, Mali.

      Design:

        -  For the first 2 days and nights, participants will stay in the hospital.

        -  They will have their medical history taken, and a physical exam.

        -  Blood will be drawn from a thin tube inserted in their hand or forearm. This will be
           done 3 times overall. A drop of blood will be taken from a finger prick 12 times
           overall.

        -  An antimalarial drug will be injected into the tube in the arm 4 times. Each time the
           drug is given, participants will drink a small cup of either water or activated
           charcoal.

        -  For the following 3 days, participants will take an antimalarial pill.

        -  On day 7, participants will visit the hospital. A drop of blood from a finger prick will
           be tested for malaria parasites.
    

Eligibility criteria:

        -  INCLUSION CRITERIA

               1. Age 2 to 10 years, inclusive

               2. Resident of Kenieroba

               3. Uncomplicated malaria*

               4. P. falciparum density 10,000 70,000/micro L, inclusive

               5. Willingness to participate in the study as evidenced by informed consent of the
                  child s parent or guardian

               6. Ability to swallow oral medication

        Uncomplicated malaria: axillary temperature >37.5oC or history of fever in the past few
        days and no criteria of SM (see next paragraph) and no other etiologies of febrile illness
        (e.g., respiratory tract infection) on clinical examination.

        Severe P. falciparum malaria: parasitemia of any density and any one of the following: coma
        (Blantyre coma score less than or equal to 2), convulsions (witnessed by investigator),
        severe prostration, severe anemia (hemoglobin less than or equal to 6 g/dl), respiratory
        distress, hypoglycemia (serum glucose less than or equal to 40 mg/dl), jaundice/icterus,
        shock (systolic blood pressure less than or equal to 70 mmHg, rapid pulse, cool
        extremities), cessation of eating and drinking, repetitive vomiting.

        EXCLUSION CRITERIA

          1. Severe malaria

          2. Any medical condition or history, including allergy to AS, AQ, artemether or
             lumefantrine, that poses a risk to the prospective participant

          3. Any condition that in the opinion of the investigator would render the participant
             unable to comply with the protocol (e.g., psychiatric disease)

          4. Any health condition that in the opinion of the investigator would confound data
             analysis or pose unnecessary risks to study participants (e.g., severe malnutrition,
             acquired or inherited immunodeficiency)

          5. Requirement for any medication for any concurrent illness or condition

          6. Participation on cohort study #13-I-N107

          7. Repetitive vomiting