- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01955382
Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria
Effect of Oral Activated Charcoal on Parasite Clearance Rates in Response to Intravenous Artesunate in Malian Children With Uncomplicated Plasmodium Falciparum Malaria
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bamako, Mali
- Universite des Sciencies, Techniques et Technologies de Bamako
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
- Age 2 to 10 years, inclusive
- Resident of Kenieroba
- Uncomplicated malaria*
- P. falciparum density 10,000 70,000/micro L, inclusive
- Willingness to participate in the study as evidenced by informed consent of the child s parent or guardian
- 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
- Severe malaria
- Any medical condition or history, including allergy to AS, AQ, artemether or lumefantrine, that poses a risk to the prospective participant
- Any condition that in the opinion of the investigator would render the participant unable to comply with the protocol (e.g., psychiatric disease)
- 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)
- Requirement for any medication for any concurrent illness or condition
- Participation on cohort study #13-I-N107
- Repetitive vomiting
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AS + oAC
All children will receive Artesunate (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 (Actidose Aqua) (Table 1) at 0, 6, 12, and 18 h.
All children will then receive amodiaquine.
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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.
Other Names:
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
Other Names:
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.
Other Names:
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Placebo Comparator: AS only (water)
Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.
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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
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parasite Clearance Half-life
Time Frame: During patient treatment
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To compare parasite clearance half-life in patients treated with IV AS + oAC or IV AS alone; parasite clearance half-life is the time it takes for the parasite density to decrease by half, and can be assessed by analysing frequent parasite density counts at 0, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after initiating treatment.
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During patient treatment
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Safety
Time Frame: During patient treatment up to 48 hours
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To assess the safety of adjunct treatment with oAC; specifically, children were hospitalized while their vital signs were measured, IV site inspected, state of consciousness assessed, and selected symptoms (nausea, vomiting, diarrhea, constipation, abdominal pain, headache, and dizziness) surveyed at 0, 2, 4, 6, 8, and 12 hours, and then every 6 hours until 48 hours or until parasitemia became undetectable (one negative thick blood film), whichever was later.
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During patient treatment up to 48 hours
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Protective Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antidotes
- Antimalarials
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Artesunate
- Charcoal
- Amodiaquine
Other Study ID Numbers
- 999913209
- 13-I-N209 (Other Identifier: NIAID IRB)
- NCT01955382 (Registry Identifier: ClinicalTrials.gov)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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