Back to resultsSafety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
Primary Purpose
Malaria
Status
Completed
Phase
Phase 2
Locations
Burkina Faso
Study Type
Interventional
Intervention
Methylenblue-Amodiaquine (MB-AQ)
Methylenblue-Artesunate (MB-AS)
Artesunate-Amodiaquine (AS-AQ)
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
Eligibility Criteria
Inclusion Criteria:
- 0.5-5 year (6-59 months) old children
- uncomplicated malaria caused by P. falciparum
- asexual parasites ≥ 2000/µ and ≤ 200000/µ
- axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
- Burkinabe nationality
- informed consent
Exclusion Criteria:
- complicated or severe malaria
- any apparent significant disease
- anaemia (haematocrit < 21%)
- treated in the same trial before
- modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Sites / Locations
- Centre de Recherche en Sante de Nouna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1-Methylenblue-Amodiaquine
2-Methylenblue-Artesunate
3-Artesunate-Amodiaquine
Arm Description
Outcomes
Primary Outcome Measures
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Secondary Outcome Measures
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
Early treatment failure (ETF) rate
Late clinical failure (LCF) rate at D14 and D28
Late parasitological failure (LPF) rate at D14 and D28
Fever clearance time
Parasite clearance time
Change in haematocrit after 2,14 and 28 days compared to baseline
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
Full Information
NCT ID
NCT00545935
First Posted
October 16, 2007
Last Updated
February 2, 2009
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT00545935
Brief Title
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
Official Title
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (false)
8. Arms, Groups, and Interventions
Arm Title
1-Methylenblue-Amodiaquine
Arm Type
Active Comparator
Arm Title
2-Methylenblue-Artesunate
Arm Type
Active Comparator
Arm Title
3-Artesunate-Amodiaquine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methylenblue-Amodiaquine (MB-AQ)
Intervention Description
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
Intervention Type
Drug
Intervention Name(s)
Methylenblue-Artesunate (MB-AS)
Intervention Description
3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
Intervention Type
Drug
Intervention Name(s)
Artesunate-Amodiaquine (AS-AQ)
Intervention Description
For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
Primary Outcome Measure Information:
Title
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
Time Frame
28 days
Title
Early treatment failure (ETF) rate
Time Frame
28 days
Title
Late clinical failure (LCF) rate at D14 and D28
Time Frame
28 days
Title
Late parasitological failure (LPF) rate at D14 and D28
Time Frame
28 days
Title
Fever clearance time
Time Frame
28 days
Title
Parasite clearance time
Time Frame
28 days
Title
Change in haematocrit after 2,14 and 28 days compared to baseline
Time Frame
28 days
Title
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Eligibility Criteria
Inclusion Criteria:
0.5-5 year (6-59 months) old children
uncomplicated malaria caused by P. falciparum
asexual parasites ≥ 2000/µ and ≤ 200000/µ
axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
Burkinabe nationality
informed consent
Exclusion Criteria:
complicated or severe malaria
any apparent significant disease
anaemia (haematocrit < 21%)
treated in the same trial before
modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Mueller, Prof.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Sante de Nouna
City
Nouna
Country
Burkina Faso
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
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