Trial Outcomes & Findings for Methylene Blue Against Falciparum Malaria in Burkina Faso (NCT NCT02851108)
NCT ID: NCT02851108
Last Updated: 2020-03-25
Results Overview
Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
7 days
Results posted on
2020-03-25
Participant Flow
Participant milestones
| Measure |
AS-AQ-MB
Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.
Methylene Blue: 50 patients will receive methylene blue
|
AS-AQ-PQ
Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).
Primaquine: 50 patients will receive primaquine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
42
|
49
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methylene Blue Against Falciparum Malaria in Burkina Faso
Baseline characteristics by cohort
| Measure |
AS-AQ-MB
n=50 Participants
Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.
Methylene Blue: 50 patients will receive methylene blue
|
AS-AQ-PQ
n=50 Participants
Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).
Primaquine: 50 patients will receive primaquine
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.34 months
STANDARD_DEVIATION 12.34 • n=99 Participants
|
38.2 months
STANDARD_DEVIATION 13.93 • n=107 Participants
|
40.27 months
STANDARD_DEVIATION 13.26 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Weight
|
12.91 kg
STANDARD_DEVIATION 3.16 • n=99 Participants
|
12.18 kg
STANDARD_DEVIATION 2.98 • n=107 Participants
|
12.55 kg
STANDARD_DEVIATION 3.08 • n=206 Participants
|
|
Length of current disease episode
|
1.94 days
STANDARD_DEVIATION 1.32 • n=99 Participants
|
1.96 days
STANDARD_DEVIATION 1.28 • n=107 Participants
|
1.95 days
STANDARD_DEVIATION 1.29 • n=206 Participants
|
|
Prior treatment of current disease episode
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Any other prior illnesses within last 7 days
Yes
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Any other prior illnesses within last 7 days
No
|
46 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Temperature
|
37.80 [°C]
STANDARD_DEVIATION 0.81 • n=99 Participants
|
37.79 [°C]
STANDARD_DEVIATION 0.79 • n=107 Participants
|
37.80 [°C]
STANDARD_DEVIATION 0.79 • n=206 Participants
|
|
Hemoglobin
|
10.16 [g/dl]
STANDARD_DEVIATION 1.62 • n=99 Participants
|
9.68 [g/dl]
STANDARD_DEVIATION 1.42 • n=107 Participants
|
9.92 [g/dl]
STANDARD_DEVIATION 1.53 • n=206 Participants
|
|
P.falciparum merozoites paras. density
|
30373.60 parasites/µl blood
STANDARD_DEVIATION 32808.10 • n=99 Participants
|
23318.80 parasites/µl blood
STANDARD_DEVIATION 25199.72 • n=107 Participants
|
26846.20 parasites/µl blood
STANDARD_DEVIATION 29319.34 • n=206 Participants
|
|
P.falciparum gamotocytes parasite density (for those patients with gametocytes)
|
200.0 parasites/µl blood
STANDARD_DEVIATION 123.29 • n=99 Participants
|
170.0 parasites/µl blood
STANDARD_DEVIATION 110.58 • n=107 Participants
|
181.54 parasites/µl blood
STANDARD_DEVIATION 111.49 • n=206 Participants
|
|
G6PD phenotype
Deficient
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
G6PD phenotype
Heterozygous
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
G6PD phenotype
Normal
|
32 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysHaemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)
Outcome measures
| Measure |
AS-AQ-MB
n=50 Participants
Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.
Methylene Blue: 50 patients will receive methylene blue
|
AS-AQ-PQ
n=49 Participants
Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).
Primaquine: 50 patients will receive primaquine
|
|---|---|---|
|
Change in Haemoglobin Compared to the Baseline
|
0.18 g/dl
Standard Deviation 1.42
|
0.54 g/dl
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 28 daysmeasured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysReports of observed or self-reported adverse event
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysAcceptance of the different treatment regimens by mothers/caretakers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysmeasured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up
Outcome measures
Outcome data not reported
Adverse Events
AS-AQ-MB
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
AS-AQ-PQ
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AS-AQ-MB
n=50 participants at risk
Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.
Methylene Blue: 50 patients will receive methylene blue
|
AS-AQ-PQ
n=50 participants at risk
Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).
Primaquine: 50 patients will receive primaquine
|
|---|---|---|
|
Blood and lymphatic system disorders
Severe anemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Severe malaria
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
Other adverse events
| Measure |
AS-AQ-MB
n=50 participants at risk
Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.
Methylene Blue: 50 patients will receive methylene blue
|
AS-AQ-PQ
n=50 participants at risk
Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).
Primaquine: 50 patients will receive primaquine
|
|---|---|---|
|
Gastrointestinal disorders
Gastro-intestinal symptoms
|
28.0%
14/50 • Number of events 19
|
26.0%
13/50 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
40.0%
20/50 • Number of events 25
|
40.0%
20/50 • Number of events 35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place