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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
  Purpose

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.


Condition Intervention Phase
Malaria
 Other: Insecticide treated nets and wall liners
Other: Insecticide treated nets alone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Malaria Transmission Consortium: The Added Effects of Insecticide Treated Materials, Artemisinin-containing Combination Treatments, and Larviciding on Malaria Transmission and Illness

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence of new malaria infections [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 1730
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insecticide treated nets and wall liners 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.
Active Comparator: Insecticide treated nets alone Other: Insecticide treated nets alone
Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043796

Locations
Kenya
Kenya Medical Research Institute
Kisumu, Nyanza, Kenya
Sponsors and Collaborators
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: John E Gimnig, Ph.D. Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01043796     History of Changes
Other Study ID Numbers: CDC-NCZVED-5794
Study First Received: January 6, 2010
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Insecticide treated wall liners
Insecticide treated nets
Incidence cohort

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 21, 2013