Condition category
Infections and Infestations
Date applied
12/09/2005
Date assigned
25/11/2005
Last edited
03/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F Pagnoni

ORCID ID

Contact details

World Health Organization
Special Programme for Research and Training in Tropical Diseases (TDR)
Av Casai 53
Geneva-27
CH 1211
Switzerland
+41 (0)22 7911811
pagnonif@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A41072

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received on the 10th June 2005.

Study design

Two-arm interventional study (ecological design)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Artemisinin

Primary outcome measures

Overall and malaria-specific mortality

Secondary outcome measures

1. Incidence of severe malaria
2. Prevalence of severe anaemia

Overall trial start date

01/11/2005

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 6 to 59 months with fever (uncomplicated malaria)
2. Signs of severe disease

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

5000

Participant exclusion criteria

1. Known hypersensitivity to the drug
2. Refusal to give informed consent

Recruitment start date

01/11/2005

Recruitment end date

31/10/2008

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
+41 (0)22 791 3909
waylings@who.int

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

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

Publication citations

Additional files

Editorial Notes