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
| ISRCTN | ISRCTN09602471 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09602471 |
| Secondary identifying numbers | A60486 |
- Submission date
- 17/04/2007
- Registration date
- 25/05/2007
- Last edited
- 10/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Franco Pagnoni
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Study design | Open randomised, controlled, clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | 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(s) | Approval received from the Comité dethique pour la Recherche en Santé du Burkina (CERS-B) on the 15th February 2007. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Coartem®, cotrimoxazole |
| Primary outcome measure | 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 study start date | 01/05/2007 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 1200 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- Burkina Faso
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/tdr/topics/mim/default.htm |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
Multilateral Initiative on Malaria (MIM)
No information available
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
