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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27290841
Enrollment
225
Registered
2004-02-06
Start date
2004-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated falciparum malaria Infections and Infestations Malaria

Interventions

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

Sponsors

DSM Fine Chemicals (Austria)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children (6 - 59 months) with uncomplicated falciparum malaria 2. Greater than or equal to 2000 Plasmodium falciparum 3. Burkinabe nationality

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Incidence of severe haemolysis or other serious adverse events (SAEs).

Secondary

MeasureTime frame
Efficacy outcomes were defined according to the WHO 2003 classification system.

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026