Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian … (NCT01955382) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria
Mali70 participantsStarted 2013-09
Plain-language 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.
Who can participate
Age range
2 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
. Severe malaria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parasite Clearance Half-life
Timeframe: During patient treatment
2
Safety
Timeframe: During patient treatment up to 48 hours
Trial details
NCT IDNCT01955382
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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