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 |
| Protocol serial number | N/A |
| Sponsor | DSM Fine Chemicals (Austria) |
| Funder | DSM Fine Chemicals (Austria) - Dream Award |
- Submission date
- 12/12/2003
- Registration date
- 06/02/2004
- Last edited
- 19/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Olaf Müller
Scientific
Scientific
Department of Tropical Hygiene and Public Health
University of Heidelberg
Heidelberg
D-69120
Germany
| Phone | +49 (0)6221 56 5035 |
|---|---|
| Olaf.Mueller@urz.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chloroquine, methylene |
| Primary outcome measure(s) |
Incidence of severe haemolysis or other serious adverse events (SAEs). |
| Key secondary outcome measure(s) |
Efficacy outcomes were defined according to the WHO 2003 classification system. |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Burkina Faso
- Germany
Study participating centre
Department of Tropical Hygiene and Public Health
Heidelberg
D-69120
Germany
D-69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 22/09/2005 | Yes | No |
