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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01955382
• Date of registration: 28/09/2013
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria
• Scientific title: Effect of Oral Activated Charcoal on Parasite Clearance Rates in Response to Intravenous Artesunate in Malian Children With Uncomplicated Plasmodium Falciparum Malaria
• Date of first enrolment: September 2013
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01955382
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Mali

Contacts

• Name: Rick M Fairhurst, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA

1. Age 2 to 10 years, inclusive

2. Resident of Kenieroba

3. Uncomplicated malaria*

4. P. falciparum density 10,000 70,000/micro L, inclusive

5. Willingness to participate in the study as evidenced by informed consent of the
child s parent or guardian

6. 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

1. Severe malaria

2. Any medical condition or history, including allergy to AS, AQ, artemether or
lumefantrine, that poses a risk to the prospective participant

3. Any condition that in the opinion of the investigator would render the participant
unable to comply with the protocol (e.g., psychiatric disease)

4. 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)

5. Requirement for any medication for any concurrent illness or condition

6. Participation on cohort study #13-I-N107

7. Repetitive vomiting



Age minimum: 2 Years
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Severe Malaria

Intervention(s)

Drug: Artesunate

Drug: Amodiaquine

Drug: Actidose Aqua

Primary Outcome(s)

Parasite Clearance Half-life [Time Frame: During patient treatment]

Safety [Time Frame: During patient treatment up to 48 hours]

Secondary ID(s)

13-I-N209

999913209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/02/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01955382