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

NCT01955382 | Completed Phase 2 Results

• 3 other identifiers: 99991320913-I-N209NCT01955382
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria; Severe Malaria

Keywords

Parasite Clearance Rate; Parasite Half Life; Actidose Aqua; Severe Malaria

Outcome Measures

Primary Outcomes (2)

• Parasite Clearance Half-life

  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.

  During patient treatment

• Safety

  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.

  During patient treatment up to 48 hours

Study Arms (2)

AS + oAC

EXPERIMENTAL

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.

Drug: Actidose Aqua; Drug: Artesunate; Drug: Amodiaquine

AS only (water)

PLACEBO COMPARATOR

Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.

Drug: Artesunate; Drug: Amodiaquine

Interventions

Actidose Aqua DRUG

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.

Also known as: Oral activated charcoal

AS + oAC

Artesunate DRUG

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

Also known as: Artesunate for injection

AS + oAC; AS only (water)

Amodiaquine DRUG

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.

Also known as: Camoquine

AS + oAC; AS only (water)

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Universite des Sciencies, Techniques et Technologies de Bamako

Bamako, Mali

Location

MeSH Terms

Conditions

Malaria; Anthrax

Interventions

Charcoal; Artesunate; Injections; Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals; Artemisinins; Reactive Oxygen Species; Free Radicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Drug Administration Routes; Drug Therapy; Therapeutics; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Rick M. Fairhurst, Principal Investigator
• Organization: NIAID/NIH

rfairhurst@niaid.nih.gov

301-761-5077

Study Officials

• Rick M Fairhurst, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2013
• First Posted: October 7, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 6, 2018
• Results First Posted: February 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)