Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria

Malaria Clinical Trial

— MTC-ITWL  

Official title:

Malaria Transmission Consortium: The Added Effects of Insecticide Treated Materials, Artemisinin-containing Combination Treatments, and Larviciding on Malaria Transmission and Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043796
• Other study ID #: CDC-NCZVED-5794
• Status: Completed
• Phase: Phase 3
• First received: January 6, 2010
• Last updated: February 2, 2015
• Start date: May 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1730
• Est. completion date: December 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

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.
• Insecticide treated nets alone
Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu	Nyanza

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Bill and Melinda Gates Foundation, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new malaria infections		Monthly	No