Evaluation of Oral Activated Charcoal on the Ability of an Antimalarial Drug to Kill Parasites in Malian Children With Mild Malaria
- 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.
- To know if a common medicine called activated charcoal can reduce severe malaria symptoms.
- Children 2 to 11 years old with mild malaria who live in Kenieroba, Mali.
- 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.
Drug: Actidose Aqua
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Oral Activated Charcoal on Parasite Clearance Rates in Response to Intravenous Artesunate in Malian Children With Uncomplicated Plasmodium Falciparum Malaria|
- Serum cytokine levels at 0, 24, and 48 h [ Time Frame: Post patient recruitment ] [ Designated as safety issue: No ]
- To compare parasite clearance half-life in patients treated with oAC + IV AS or IV AS [ Time Frame: Post patient recruitment ] [ Designated as safety issue: No ]
- To assess the safety of adjunct treatment with oAC [ Time Frame: During patient recruitment and treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2013|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: AS + oAC
All children will receive AS 2.4 mg/kg IV at 0 and 12 h, 24 h, and 48 h. Children in the AS+oAC group will be given weight-based doses of oAC (Table 1) at 0, 6, 12, and 18 h.
Drug: Actidose Aqua
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.Drug: Artesunate
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 WHODrug: Amodiaquine
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.
Placebo Comparator: AS only (water)
Children in the AS only group will receive a weight based volume of clean water to drink rather than the oAC
Drug: Actidose Aqua
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01955382
|Universite des Sciencies, Techniques et Technologies de Bamako|
|Principal Investigator:||Rick M Fairhurst, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|