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Methylene Blue Against Falciparum Malaria in Burkina Faso (BlueACTn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AS-AQ-MB AS-AQ-PQ
Hide 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
Arm/Group Title AS-AQ-MB AS-AQ-PQ Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change in Haemoglobin Compared to the Baseline
Hide Description Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AS-AQ-MB AS-AQ-PQ
Hide 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
Hide 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)
Hide 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
Hide 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
Hide 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
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AS-AQ-MB AS-AQ-PQ
Hide 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   --/--      --/--    
Hide 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
Hide 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
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
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