Condition category
Infections and Infestations
Date applied
12/12/2003
Date assigned
06/02/2004
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes