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Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria (MTC-ITWL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kenya Medical Research Institute
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01043796
First received: January 6, 2010
Last updated: September 26, 2012
Last verified: September 2012
History of Changes

January 6, 2010
September 26, 2012
May 2010
June 2011   (final data collection date for primary outcome measure)
Incidence of new malaria infections [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01043796 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria
Malaria Transmission Consortium: The Added Effects of Insecticide Treated Materials, Artemisinin-containing Combination Treatments, and Larviciding on Malaria Transmission and Illness

The purpose of this study is to determine whether insecticide treated wall liners, in combination with insecticide treated nets, reduce the incidence of malaria infections compared to insecticide treated nets alone.

Insecticide treated nets (ITNs) have been shown to reduce malaria related morbidity and mortality and are increasingly being scaled up throughout sub-Saharan Africa. However, ITNs alone are unlikely to reduce transmission to zero in most settings and additional vector control tools are necessary. One new promising strategy is the use of insecticide treated wall liners (ITWLs). These are textiles treated with an insecticide that are used to line the inner walls of houses. The wall liners are considered a long-lasting alternative to indoor residual spraying which is also used for malaria vector control but is expensive to implement.

Within 6 pairs of villages, we plan to randomly allocate one village in each pair to receive either ITNs or ITNs plus ITWLs. Households will be randomly selected from each village and all children between the ages of 6 months and 11 years will be enrolled in a cohort study. The children will be cleared of existing infections and then followed monthly until they are found to be infected with malaria. The study will last for 6 months and will demonstrate whether the ITWLs provide additional protection against malaria over that provided by the use of ITNs.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Malaria
  • Other: Insecticide treated nets and wall liners
    Participants will be provided a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme. Households where participants reside will be fitted with insecticide treated wall liners.
  • Other: Insecticide treated nets alone
    Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme
  • Experimental: Insecticide treated nets and wall liners
    Intervention: Other: Insecticide treated nets and wall liners
  • Active Comparator: Insecticide treated nets alone
    Intervention: Other: Insecticide treated nets alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1730
December 2013
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 6 months up to 11 years
  • Living in the study area and remaining in the study area for the duration of the study
  • Informed consent provided by parents

Exclusion Criteria:

  • No informed consent
  • Living outside the study area, or likely to move outside study area
  • Severely ill and unlikely to be able to complete study
Both
6 Months to 11 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01043796
CDC-NCZVED-5794
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Kenya Medical Research Institute
  • Bill and Melinda Gates Foundation
Principal Investigator: John E Gimnig, Ph.D. Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP