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

Completed

• Conditions: ncomplicated falciparum malaria; Infections and Infestations; Malaria

• Registration Number: ISRCTN27290841
• Lead Sponsor: DSM Fine Chemicals (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 225

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe haemolysis or other serious adverse events (SAEs).

Secondary Outcome Measures

Name	Time	Method
Efficacy outcomes were defined according to the WHO 2003 classification system.