A two-arm interventional study to evaluate the impact of Home and community management of Malaria with Artemisinin Combination Therapy (ACT) on under five childhood mortality in two rural health districts, Burkina Faso
| ISRCTN | ISRCTN73662821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73662821 |
| Protocol serial number | A41072 |
| Sponsor | UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funder | 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) |
- Submission date
- 12/09/2005
- Registration date
- 25/11/2005
- Last edited
- 03/10/2008
- 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 F Pagnoni
Scientific
Scientific
World Health Organization
Special Programme for Research and Training in Tropical Diseases (TDR)
Av Casai 53
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 7911811 |
|---|---|
| pagnonif@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm interventional study (ecological design) |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. Home management of malaria with Artemisinin Combination Therapies (ACTs) reduces overall and malaria-specific mortality in children under five years 2. Home management of malaria with ACTs reduces progression of uncomplicated malaria to severe malaria 3. Home management of malaria with ACTs reduces the prevalence of severe anaemia in treated children Please note that as of 03/10/2008 this record was updated to include an amendment to the study design of this trial from a cluster-randomized controlled trial to a two-arm interventional study (ecological design, 1 zone intervention, 1 zone control). Changes can be found in the study design and title sections; the initial details were as follows: Initial title: A clustered randomised controlled trial to evaluate the impact of Home and community management of Malaria with Artemisinin Combination Therapy (ACT) on under five childhood mortality in two rural health districts, Burkina Faso Initial study design: Epidemiological, health systems, randomised trial. |
| Ethics approval(s) | Ethics approval received on the 10th June 2005. |
| Health condition(s) or problem(s) studied | Uncomplicated malaria |
| Intervention | 1. Training of community-based drug distributors - Y1 2. Develop and implement a communication for behaviour change strategy - Y1 to Y3 3. Avail pre-packaged unit dosed ACTs (Coartem); ACTs will be deployed at health facility (HF) and community level in the intervention areas, at HF level only in control areas - Y2 and Y3 4. Implement a community based vital statistics monitoring system in the study communities 5. Evaluate the impact of the strategy on overall and malaria-specific mortality in children under five years - Y2 and Y3 |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artemisinin |
| Primary outcome measure(s) |
Overall and malaria-specific mortality |
| Key secondary outcome measure(s) |
1. Incidence of severe malaria |
| Completion date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | All |
| Target sample size at registration | 5000 |
| Key inclusion criteria | 1. Children aged 6 to 59 months with fever (uncomplicated malaria) 2. Signs of severe disease |
| Key exclusion criteria | 1. Known hypersensitivity to the drug 2. Refusal to give informed consent |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 31/10/2008 |
Locations
Countries of recruitment
- Burkina Faso
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
