Phase 2 N=70 Randomized Treatment

Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria

Malaria · Severe Malaria

Bottom Line

View on ClinicalTrials.gov: NCT01955382 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Parasite Clearance Half-life — 1.733; 1.973 Hours — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Actidose Aqua (Drug); Artesunate (Drug); Amodiaquine (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Parasite Clearance Half-life	1.733; 1.973	>0.05
PRIMARY Safety	35; 35	—

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
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

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Data sourced from ClinicalTrials.gov (NCT01955382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.