Contact information
Type
Scientific
Primary contact
Dr Olaf Müller
ORCID ID
Contact details
Department of Tropical Hygiene and Public Health
University of Heidelberg
Heidelberg
D-69120
Germany
+49 (0)6221 56 5035
Olaf.Mueller@urz.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BlueCQ2
Study hypothesis
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
The protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University and the local Ethics Committee in Burkina Faso.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Chloroquine, methylene
Primary outcome measures
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 trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children (6 - 59 months) with uncomplicated falciparum malaria
2. Greater than or equal to 2000 Plasmodium falciparum
3. Burkinabe nationality
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
225
Participant 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)
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
Department of Tropical Hygiene and Public Health
Heidelberg
D-69120
Germany
Sponsor information
Organisation
DSM Fine Chemicals (Austria)
Sponsor details
c/o Dr. Wolfgang Schiek
St. Peter-Str. 25
PO Box 933
Linz
A-4021
Austria
+43 (0)732 6916 2150
wolfgang.schiek@dsm.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
DSM Fine Chemicals (Austria) - Dream Award
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/16179085
Publication citations
-
Results
Meissner PE, Mandi G, Witte S, Coulibaly B, Mansmann U, Rengelshausen J, Schiek W, Jahn A, Sanon M, Tapsoba T, Walter-Sack I, Mikus G, Burhenne J, Riedel KD, Schirmer H, Kouyaté B, Müller O, Safety of the methylene blue plus chloroquine combination in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso [ISRCTN27290841]., Malar. J., 2005, 4, 45, doi: 10.1186/1475-2875-4-45.