Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A60486
Study information
Scientific title
Acronym
Study hypothesis
Community level treatment of malaria and/or acute respiratory infections guided by malaria Rapid Diagnostic Testing (RDT) and respiratory rate counting improves clinical recovery rate of children with febrile disease.
Ethics approval
Approval received from the Comité dethique pour la Recherche en Santé du Burkina (CERS-B) on the 15th February 2007.
Study design
Open randomised, controlled, clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Malaria, acute respiratory infection
Intervention
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 after the onset of the treatment
Principal Investigator:
Tiono Alfred
Centre National de Recherche et de Formation sur le Paludisme
01 BP 2208
Ouagadougou 01
Burkina Faso
Tel: +226 70 28 57 26
Email: t.alfred@fasonet.bf
Intervention type
Drug
Phase
Not Specified
Drug names
Coartem®, cotrimoxazole
Primary outcome measures
Clinical recovery rate at 72 hours after treatment (defined as apyrexia and axillary temperature less than 37.5°C).
Secondary outcome measures
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
Overall trial start date
01/05/2007
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1200
Participant 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
Recruitment start date
01/05/2007
Recruitment end date
01/05/2008
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Multilateral Initiative on Malaria (MIM)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary