Methylene Blue Against Falciparum Malaria in Burkina Faso (BlueACTn)

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ClinicalTrials.gov Identifier: NCT02851108

Recruitment Status : Completed

First Posted : August 1, 2016

Results First Posted : March 25, 2020

Last Update Posted : March 25, 2020

Sponsor:

Collaborator:

Centre de Recherche en Sante de Nouna, Burkina Faso

Information provided by (Responsible Party):

Olaf Mueller, Heidelberg University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Malaria, Falciparum
Interventions	Drug: Methylene Blue Drug: Primaquine
Enrollment	100

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	AS-AQ-MB	AS-AQ-PQ
Arm/Group Description	Once daily a fixed dose artesunate-...	Once daily a fixed dose artesunate-...
Arm/Group Description	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	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
Period Title: Overall Study
Started	50	50
Completed	42	49
Not Completed	8	1

Baseline Characteristics

Arm/Group Title		AS-AQ-MB	AS-AQ-PQ	Total
Arm/Group Description		Once daily a fixed dose artesunate-...	Once daily a fixed dose artesunate-...	Total of all reporting groups
Arm/Group Description		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	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 of all reporting groups
Overall Number of Baseline Participants		50	50	100
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Months
	Number Analyzed	50 participants	50 participants	100 participants
		42.34 (12.34)	38.2 (13.93)	40.27 (13.26)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants	50 participants	100 participants
	Female	24 48.0%	25 50.0%	49 49.0%
	Male	26 52.0%	25 50.0%	51 51.0%
Weight Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	50 participants	50 participants	100 participants
		12.91 (3.16)	12.18 (2.98)	12.55 (3.08)
Length of current disease episode Mean (Standard Deviation) Unit of measure: Days
	Number Analyzed	50 participants	50 participants	100 participants
		1.94 (1.32)	1.96 (1.28)	1.95 (1.29)
Prior treatment of current disease episode Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants	50 participants	100 participants
		16 32.0%	13 26.0%	29 29.0%
Any other prior illnesses within last 7 days Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	50 participants	50 participants	100 participants
Yes		4 8.0%	2 4.0%	6 6.0%
No		46 92.0%	48 96.0%	94 94.0%
Temperature Mean (Standard Deviation) Unit of measure: [°C]
	Number Analyzed	50 participants	50 participants	100 participants
		37.80 (0.81)	37.79 (0.79)	37.80 (0.79)
Hemoglobin Mean (Standard Deviation) Unit of measure: [g/dl]
	Number Analyzed	50 participants	50 participants	100 participants
		10.16 (1.62)	9.68 (1.42)	9.92 (1.53)
P.falciparum merozoites paras. density Mean (Standard Deviation) Unit of measure: Parasites/µl blood
	Number Analyzed	50 participants	50 participants	100 participants
		30373.60 (32808.10)	23318.80 (25199.72)	26846.20 (29319.34)
P.falciparum gamotocytes parasite density (for those patients with gametocytes) Mean (Standard Deviation) Unit of measure: Parasites/µl blood
	Number Analyzed	50 participants	50 participants	100 participants
		200.0 (123.29)	170.0 (110.58)	181.54 (111.49)
G6PD phenotype Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants	50 participants	100 participants
	Deficient	7 14.0%	7 14.0%	14 14.0%
	Heterozygous	11 22.0%	5 10.0%	16 16.0%
	Normal	32 64.0%	38 76.0%	70 70.0%

Outcome Measures

1.Primary Outcome


Title	Change in Haemoglobin Compared to the Baseline
Description	Haemoglobin concentrations will be measured in the field using a HemoC...
Description	Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	AS-AQ-MB	AS-AQ-PQ
Arm/Group Description:	Once daily a fixed dose artesunate-...	Once daily a fixed dose artesunate-...
Arm/Group Description:	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	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 Number of Participants Analyzed	50	49
Mean (Standard Deviation) Unit of Measure: g/dl
	0.18 (1.42)	0.54 (0.94)

2.Secondary Outcome


Title	Gametocyte Prevalence
Description	measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28...
Description	measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up
Time Frame	28 days

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	Adverse Events (AE)
Description	Reports of observed or self-reported adverse event
Description	Reports of observed or self-reported adverse event
Time Frame	28 days

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	Mothers/Caretakers Questionnaire on Acceptance
Description	Acceptance of the different treatment regimens by mothers/caretakers
Description	Acceptance of the different treatment regimens by mothers/caretakers
Time Frame	14 days

Outcome Measure Data Not Reported

5.Secondary Outcome


Title	Gametocyte Density
Description	measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28...
Description	measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up
Time Frame	28 days

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	AS-AQ-MB		AS-AQ-PQ
Arm/Group Description	Once daily a fixed dose artesunate-...		Once daily a fixed dose artesunate-...
Arm/Group Description	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		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
All-Cause Mortality
	AS-AQ-MB		AS-AQ-PQ
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	AS-AQ-MB		AS-AQ-PQ
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/50 (4.00%)		0/50 (0.00%)
Blood and lymphatic system disorders
Severe anemia ^†	1/50 (2.00%)	1	0/50 (0.00%)	0
Infections and infestations
Severe malaria ^†	1/50 (2.00%)	1	0/50 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AS-AQ-MB		AS-AQ-PQ
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/50 (66.00%)		28/50 (56.00%)
Gastrointestinal disorders
Gastro-intestinal symptoms ^†	14/50 (28.00%)	19	13/50 (26.00%)	16
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms ^†	20/50 (40.00%)	25	20/50 (40.00%)	35
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Prof. Dr. Olaf Müller
Organization:	Heidelberg University
Phone:	+49 6221 56 4904
EMail:	olaf.mueller@urz.uni-heidelberg.de

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mendes Jorge M, Ouermi L, Meissner P, Compaoré G, Coulibaly B, Nebie E, Krisam J, Klose C, Kieser M, Jahn A, Lu G, D Alessandro U, Sié A, Mockenhaupt FP, Müller O. Safety and efficacy of artesunate-amodiaquine combined with either methylene blue or primaquine in children with falciparum malaria in Burkina Faso: A randomized controlled trial. PLoS One. 2019 Oct 10;14(10):e0222993. doi: 10.1371/journal.pone.0222993. eCollection 2019.

Layout table for additonal information

Responsible Party:	Olaf Mueller, Heidelberg University
ClinicalTrials.gov Identifier:	NCT02851108
Other Study ID Numbers:	UniHD008
First Submitted:	June 28, 2016
First Posted:	August 1, 2016
Results First Submitted:	March 11, 2020
Results First Posted:	March 25, 2020
Last Update Posted:	March 25, 2020

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