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
Secondary identifying numbers	A41072

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

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
Email	pagnonif@who.int

Study information

Study design	Two-arm interventional study (ecological design)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artemisinin
Primary outcome measure	Overall and malaria-specific mortality
Secondary outcome measures	1. Incidence of severe malaria 2. Prevalence of severe anaemia
Overall study start date	01/11/2005
Completion date	31/10/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	Both
Target number of participants	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

Sponsor information

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

World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)22 791 3909
Email	waylings@who.int
Website	http://www.who.int
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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