Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-02-01

Brief Summary

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The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides or an insecticide and a synergist have been developed to control resistant mosquitoes.

The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist, piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin.

The primary outcome of the trial will be cross-sectional community prevalence of malaria infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months post-intervention.

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Detailed Description

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Conditions

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Malaria Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Pyriproxyfen LLIN

Royal Guard® (Disease Control Technologies, LLC) is a Long Lasting Insecticidal Net made of polyethylene incorporating a mixture of 225 mg/m2 pyriproxyfen and 261mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.

Group Type EXPERIMENTAL

pyriproxyfen LLIN

Intervention Type OTHER

Dual active ingredient Long Lasting Insecticidal Net

Chlorfenapyr LLIN

Interceptor® G2 (BASF corporation) is a LLIN made of polyester coated with a wash-resistant formulation of 200 mg/m2 chlorfenapyr and 100 mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.

Group Type EXPERIMENTAL

Chlorfenapyr LLIN

Intervention Type OTHER

Dual active ingredient Long Lasting Insecticidal Net

Piperonyl butoxide LLIN

Olyset® Plus (Sumitomo Chemicals) is a LLIN combining Piperonyl butoxide (400mg/m2) and the repellent pyrethroid permethrin (800 mg/m2) incorporated into the polyethylene fibres. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.

Group Type EXPERIMENTAL

Piperonyl butoxide LLIN

Intervention Type OTHER

Combination insecticide and synergist Long Lasting Insecticidal Net

Standard LLIN

Interceptor® (BASF Corporation) is a single pyrethroid-treated LLIN with alpha-cypermethrin (coated onto filaments) at a target dose of 200 mg/m2 of polyester fabric. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.

Group Type ACTIVE_COMPARATOR

Standard LLIN

Intervention Type OTHER

Standard Long Lasting Insecticidal Net with one insecticide

Interventions

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Chlorfenapyr LLIN

Dual active ingredient Long Lasting Insecticidal Net

Intervention Type OTHER

pyriproxyfen LLIN

Dual active ingredient Long Lasting Insecticidal Net

Intervention Type OTHER

Piperonyl butoxide LLIN

Combination insecticide and synergist Long Lasting Insecticidal Net

Intervention Type OTHER

Standard LLIN

Standard Long Lasting Insecticidal Net with one insecticide

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least one child between 6 months to 14 years old having permanent residence in selected household
* Having an adult caregiver willing to provide written consent for the household and clinical survey