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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN09602471
Enrollment
1200
Registered
2007-05-25
Start date
2007-05-01
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

Malaria, acute respiratory infection Infections and Infestations Malaria

Interventions

Patients were randomised between: 1. Treatment with Coartem® and/or cotrimoxazole based on rapid diagnosis test results and respiratory rate count 2. Presumptive treatment with Coartem®, on day three

Sponsors

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Clinical recovery rate at 72 hours after treatment (defined as apyrexia and axillary temperature less than 37.5°C).

Secondary

MeasureTime frame
1. Evaluate influence of the seasonal variation of malaria transmission on the impact, measured at eight days post onset of the treatment 2. Assess the cost-effectiveness of RDT in the context of the HMM strategy with Coartem®, measured at the end of the study 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

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026