Trial Outcomes & Findings for Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria (NCT NCT01955382)
NCT ID: NCT01955382
Last Updated: 2018-02-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
During patient treatment
Results posted on
2018-02-06
Participant Flow
Participant milestones
| Measure |
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.
Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US 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.
Artesunate: 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
Amodiaquine: 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.
|
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.
Artesunate: 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
Amodiaquine: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria
Baseline characteristics by cohort
| Measure |
AS + oAC
n=35 Participants
All children in the AS+oAC group will receive artesunate (AS) 2.4 mg/kg IV at 0, 12, 24, and 48 h, and weight-based doses of oral activated charcoal (oAC; Actidose Aqua; according to Table 1) at 0, 6, 12, and 18 h. All children will then receive age-based doses of amodiaquine.
|
AS Only (Water)
n=35 Participants
All children in the AS Only group will receive artesunate (AS) 2.4 mg/kg IV at 0, 12, 24, and 48 h, and weight-based volumes of clean water at 0, 6, 12, and 18 h. All children will then receive age-based doses of amodiaquine.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.314 years
STANDARD_DEVIATION 2.166 • n=5 Participants
|
5.600 years
STANDARD_DEVIATION 2.117 • n=7 Participants
|
5.896 years
STANDARD_DEVIATION 2.168 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Weight
|
19.29 Kilograms
STANDARD_DEVIATION 5.120 • n=5 Participants
|
17.87 Kilograms
STANDARD_DEVIATION 4.568 • n=7 Participants
|
18.59 Kilograms
STANDARD_DEVIATION 4.868 • n=5 Participants
|
|
Hemoglobin concentration
|
10.93 grams per deciliter
STANDARD_DEVIATION 3.193 • n=5 Participants
|
10.15 grams per deciliter
STANDARD_DEVIATION 1.047 • n=7 Participants
|
10.54 grams per deciliter
STANDARD_DEVIATION 2.391 • n=5 Participants
|
|
Temperature
|
36.37 degrees Celsius
STANDARD_DEVIATION 0.3511 • n=5 Participants
|
36.45 degrees Celsius
STANDARD_DEVIATION 0.3988 • n=7 Participants
|
36.41 degrees Celsius
STANDARD_DEVIATION 0.3751 • n=5 Participants
|
|
Parasite density
|
4.421 log10(parasites per microliter)
STANDARD_DEVIATION 0.2569 • n=5 Participants
|
4.459 log10(parasites per microliter)
STANDARD_DEVIATION 0.2592 • n=7 Participants
|
4.440 log10(parasites per microliter)
STANDARD_DEVIATION 0.2569 • n=5 Participants
|
PRIMARY outcome
Timeframe: During patient treatmentTo 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.
Outcome measures
| Measure |
AS + oAC
n=35 Participants
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.
Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US 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.
Artesunate: 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
Amodiaquine: 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.
|
AS Only (Water)
n=35 Participants
Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.
Artesunate: 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
Amodiaquine: 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.
|
|---|---|---|
|
Parasite Clearance Half-life
|
1.733 Hours
Standard Deviation 0.7206
|
1.973 Hours
Standard Deviation 0.6221
|
PRIMARY outcome
Timeframe: During patient treatment up to 48 hoursPopulation: Children who received treatment per protocol
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.
Outcome measures
| Measure |
AS + oAC
n=35 Participants
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.
Actidose Aqua: Actidose Aqua (oAC, Paddock Laboratories) is sold over the counter in the US 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.
Artesunate: 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
Amodiaquine: 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.
|
AS Only (Water)
n=35 Participants
Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.
Artesunate: 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
Amodiaquine: 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.
|
|---|---|---|
|
Safety
|
35 Participants
|
35 Participants
|
Adverse Events
AS + oAC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AS Only (Water)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AS + oAC
n=35 participants at risk
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.
Actidose Aqua: Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the US 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.
Artesunate: 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
Amodiaquine: 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.
|
AS Only (Water)
n=35 participants at risk
Children in the AS only group will receive a weight-based volume of clean water (Bottled Water) to drink rather than the oAC.
Artesunate: 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
Amodiaquine: 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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • Number of events 2 • Up to 72 hours
|
8.6%
3/35 • Number of events 3 • Up to 72 hours
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Number of events 2 • Up to 72 hours
|
0.00%
0/35 • Up to 72 hours
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • Up to 72 hours
|
0.00%
0/35 • Up to 72 hours
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/35 • Up to 72 hours
|
2.9%
1/35 • Number of events 1 • Up to 72 hours
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • Up to 72 hours
|
2.9%
1/35 • Number of events 1 • Up to 72 hours
|
Additional Information
Dr. Rick M. Fairhurst, Principal Investigator
NIAID/NIH
Phone: 301-761-5077
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place