Safety and efficacy of the combination of chloroquine and methylene blue in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso

ISRCTN	ISRCTN27290841
DOI	https://doi.org/10.1186/ISRCTN27290841
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Olaf Müller
Scientific

Department of Tropical Hygiene and Public Health
University of Heidelberg
Heidelberg
D-69120
Germany

Phone	+49 (0)6221 56 5035
Email	Olaf.Mueller@urz.uni-heidelberg.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	BlueCQ2
Study objectives	Safe, effective and affordable drug combinations against falciparum malaria are urgently needed for the poor populations in malaria endemic countries. Methylene blue (MB) combined with chloroquine (CQ) has been considered as one promising new regimen.
Ethics approval(s)	The protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University and the local Ethics Committee in Burkina Faso.
Health condition(s) or problem(s) studied	Uncomplicated falciparum malaria
Intervention	Arm A (N = 45): 25 mg/kg oral chloroquine within 3 days Arm B (N = 180): 25 mg/kg oral chloroquine and 15 mg/kg methylene blue within 3 days
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Chloroquine, methylene
Primary outcome measure	Incidence of severe haemolysis or other serious adverse events (SAEs).
Secondary outcome measures	Efficacy outcomes were defined according to the WHO 2003 classification system.
Overall study start date	01/01/2004
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	Not Specified
Target number of participants	225
Key inclusion criteria	1. Children (6 - 59 months) with uncomplicated falciparum malaria 2. Greater than or equal to 2000 Plasmodium falciparum 3. Burkinabe nationality
Key exclusion criteria	1. Complicated or severe malaria (repeated vomiting, seizures or other neurological impairment) 2. Anaemia (haemoglobin less than 8 g/dl or haematocrit less than 24%) 3. Any other apparent significant disease (e.g. pneumonia, meningitis, hepatitis, severe diarrhoea, measles, severe malnutrition)
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2004

Department of Tropical Hygiene and Public Health

Heidelberg
D-69120
Germany

DSM Fine Chemicals (Austria)
Industry

c/o Dr. Wolfgang Schiek
St. Peter-Str. 25
PO Box 933
Linz
A-4021
Austria

Industry

DSM Fine Chemicals (Austria) - Dream Award

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	22/09/2005		Yes	No