Condition category
Infections and Infestations
Date applied
16/07/2007
Date assigned
19/07/2007
Last edited
19/09/2008
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

Prof Olaf Mueller

ORCID ID

Contact details

Im Neuenheimer Feld 324
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D4

Study information

Scientific title

Acronym

Study hypothesis

There is the highly controversial question how African programmes can best reach a sustainable high coverage with Insecticide-Treated bed Nets (ITNs) in young children and pregnant women. Against this background a cluster randomised controlled trial is implemented in Nouna Health District in Burkina Faso to compare two different forms of distribution of ITNs.

Ethics approval

The protocol has been reviewed and approved by the Ethics Committee of the University of Heidelberg (date: 12 th November 2004, ref: L-357/2004) and the local Ethics Committee in Nouna, Burkina Faso.

Study design

Cluster-randomised controlled trial. Evaluation takes place through annual representative household surveys.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Malaria

Intervention

Twenty-four peripheral health centres and their catchment areas were randomised to:
1. ITN provision to the general population through social marketing, and
2. ITN provision to the general population through social marketing plus free provision to all pregnant women through antenatal services

The total duration of the intervention will be three years, and participants will be followed up for a further two years.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. ITN coverage in households 12 and 24 months after the start of the interventions
2. ITN use during pregnancy and infancy

Secondary outcome measures

1. Costs per malaria case and per Disability Adjusted Life Years (DALY) prevented
2. Self-reported information on Antenatal Clinic (ANC) visits
3. Insecticide content on ITN and mortality of vector mosquitoes over time
4. Acceptance of health staff and population

Outcomes will be measured at 12 and 24 months after the start of the interventions

Overall trial start date

01/08/2006

Overall trial end date

30/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Households with children under five years of age.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

sample size: 500 per study arm

Participant exclusion criteria

No exclusion criteria.

Recruitment start date

01/08/2006

Recruitment end date

30/12/2008

Locations

Countries of recruitment

Burkina Faso

Trial participating centre

Im Neuenheimer Feld 324
Heidelberg
69120
Germany

Sponsor information

Organisation

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Sponsor details

Im Neuenheimer Feld 672
Heidelberg
69120
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.klinikum.uni-heidelberg.de/

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - Special Research Area of Control of Tropical Infectious Diseases (Sonderforschungsbereich [SFB] 544)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18784840

Publication citations

  1. Results

    Müller O, De Allegri M, Becher H, Tiendrebogo J, Beiersmann C, Ye M, Kouyate B, Sie A, Jahn A, Distribution systems of insecticide-treated bed nets for malaria control in rural Burkina Faso: cluster-randomized controlled trial., PLoS ONE, 2008, 3, 9, e3182, doi: 10.1371/journal.pone.0003182.

Additional files

Editorial Notes