Role of rapid diagnostic testing in the context of home management of childhood fever with Coartem®: an open randomised controlled trial in a rural and seasonal malaria transmission area of Burkina Faso
- Conditions
- Malaria, acute respiratory infectionInfections and InfestationsMalaria
- Registration Number
- ISRCTN09602471
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1200
1. Written informed consent from parent/guardian
2. Aged 6 to 59 months
3. Weight equals 5 kg
4. Willing to comply with the study procedures
5. History of fever within the last 24 hours or documented fever (axillary temperature equals 37.5°C)
1. Severe malaria
2. Danger signs (unable to drink or eat, incoercible vomiting, convulsions, prostration)
3. History of allergic reaction to the study drugs
4. History of treatment with artemisinin derivatives in the past seven days
5. Previous participation in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical recovery rate at 72 hours after treatment (defined as apyrexia and axillary temperature less than 37.5°C).
- Secondary Outcome Measures
Name Time Method 1. Evaluate influence of the seasonal variation of malaria transmission on the impact, measured at eight days post onset of the treatment<br>2. Assess the cost-effectiveness of RDT in the context of the HMM strategy with Coartem®, measured at the end of the study <br>3. Describe the operational feasibility and acceptability of RDT in the context of the HMM strategy with Coartem®, measured at the end of the study