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Evaluation of Long-Lasting Microbial Larvicides in Reducing Malaria Transmission and Clinical Malaria Incidence

NCT02392832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240000

Last updated 2021-03-29

No results posted yet for this study

Summary

In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual spraying (IRS), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in African highlands. However, rising insecticide resistance and increased outdoor transmission have greatly hampered the effectiveness of ITN and IRS because the current indoor-based interventions do not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The central objective of this study is to determine the efficacy and cost-effectiveness of EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence in western Kenya highlands.

Conditions

Interventions

BIOLOGICAL

Fourstar® granule, 90 day and 180 day briquettes Bti/Bs

In 2015: Two sites each in Kakamega and Vihiga counties in western Kenya will be randomly selected and treated with larvicides (intervention) and the other two sites will serve as control (no-intervention). Temporary habitats will be treated with FourStar® controlled release granule formulation, semi-permanent habitats will be treated with 90 day briquettes, and permanent habitats with 180 day briquettes. No retreatment. Starts from 2016, a total of 34 clusters in the two study sites will be assigned to treatment or control by a block randomization method. The Bti treatment will be the same as in 2015. The retreatment interval will be 4-5 months. After the third treatment, no treatment will be performed for the next 8 months. After this, a cross over will be performed. Previous control sites will receive 3 rounds of the same LLML treatment at appropriate time intervals and previous treatment sites will not receive any LLMLs.

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Guiyun Yan, Ph.D. · University of California at Irvine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
7 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392832 on ClinicalTrials.gov