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The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania (DL)

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ClinicalTrials.gov Identifier: NCT02533336
Recruitment Status : Terminated (futility ground)
First Posted : August 26, 2015
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
London School of Hygiene and Tropical Medicine
Centers for Disease Control and Prevention
Brandeis University
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Dr. Geofrey Makenga, National Institute for Medical Research, Tanzania

Brief Summary:
Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological parameters. Information on the relative cost-effectiveness estimates of DL and the community acceptability of DL will also be measured.

Condition or disease Intervention/treatment Phase
Malaria Drug: abamectin and fenpyroximate Phase 3

Detailed Description:

Vector control, together with prompt treatment with an artemisinin-based combination therapy (ACT) for individuals diagnosed with malaria and intermittent preventive treatment in pregnant women, is a critical component of malaria control in Africa. The two main vector control interventions used in Africa are long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS). LLINs are currently the mainstay of vector control and are believed to have contributed to the recent dramatic decline in malaria cases. However, resistance to the pyrethroid insecticides used in the bed nets has increased. The second main vector control method, IRS, has been an extremely effective adjunct to LLINs; its usefulness is threatened by the high cost of repeated applications and increasing mosquito resistance to insecticides used for spraying.

A new product, durable lining (DL) treated with non-pyrethroid insecticides, has been developed by Vestergaard, which theoretically mimics the effect of IRS but is designed to last for a minimum of three years. The product consists of a mixture of two non-pyrethroid insecticides incorporated into a polymer fabric that are designed to migrate differentially over the lifetime of the product to ensure sustained bioefficacy. The use of two agents may also decrease the risk of development of resistance. It is estimated that the cost of the insecticide treated wall liners (DL), which are installed on the indoor walls of houses, would be equal to 2-3 rounds of IRS.

To test the effectiveness of this new product, we will conduct a two-arm controlled randomized cluster trial to test the hypothesis that DL + LLINs are superior to LLINs alone. Over twelve (12) months (August 2015- Aug 2016), in an area with universal coverage (UC) of LLINs and where artemisinin combination therapies (ACT) are provided as the first-line treatment of malaria, we intend to evaluate the impact of DL on malaria transmission among children ages 6 months to 11 years as measured by the incidence of malaria parasitemia (symptomatic and asymptomatic), and the prevalence of moderate to severe anemia in under-fives. In addition, we will assess the effect of DL on entomological parameters, and measure the acceptability and a cost-effectiveness of the intervention. Stratified randomization based on malaria prevalence during the baseline survey will be used to select 22 clusters per arm in Muheza district.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4917 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania: Cluster Randomized Trial
Actual Study Start Date : November 9, 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: DL+LLINs
DL treated with abamectin and fenpyroximate
Drug: abamectin and fenpyroximate
No Intervention: LLINs
LLINs only



Primary Outcome Measures :
  1. Incidence of malaria parasitemia [ Time Frame: 1 year ]
    The primary end point of the study is the cumulative incidence of malaria parasitaemia (asymptomatic or symptomatic) defined as the number of mRDT-confirmed episodes of parasitaemia per person-year


Secondary Outcome Measures :
  1. Effectiveness of DL on anemia [ Time Frame: 1 year ]
    change in mean haemoglobin in the intervention arm compared to the control



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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Permanent residence in a selected household
  • Aged 6 months- 11years for cohort study
  • Informed parental consent
  • For children between 8-11 years old, written assent

Exclusion criteria:

  • Severely ill and unlikely to be able to complete the study
  • Family does not intend to remain in the study area during the study period, or through the long rains
  • Household does not accept intervention
  • Not living in the study area when interventions were implemented
  • enrolled in other interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533336


Locations
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Tanzania
Muheza
Tanga, Muheza, Tanzania, 255
Sponsors and Collaborators
National Institute for Medical Research, Tanzania
Kilimanjaro Christian Medical Centre, Tanzania
London School of Hygiene and Tropical Medicine
Centers for Disease Control and Prevention
Brandeis University
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: William N Kisinza, PhD National Institute for Medical Research
Study Director: Joseph P Mugasa, PhD National Institute for Medical Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Geofrey Makenga, Research Scientist, National Institute for Medical Research, Tanzania
ClinicalTrials.gov Identifier: NCT02533336    
Other Study ID Numbers: DL Project in Tanzania
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by Dr. Geofrey Makenga, National Institute for Medical Research, Tanzania:
Malaria control
Insecticide treated durable Wall Liners
Malaria incidence
Randomized Trial
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Abamectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents