Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Anaemia; Malaria

Treatments: Other: Standard LLIN; Other: pyriproxyfen LLIN; Other: Piperonyl butoxide LLIN; Other: Chlorfenapyr LLIN

Study type: Interventional

Funder types: Other

Identifiers

NCT03554616

ITDCZN11

Details and patient eligibility

About

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.

Enrollment: 4,200 patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Dwelling not found or vacant during the survey
• No adult caregiver capable to give informed consent
• Children severely ill

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4,200 participants in 4 patient groups

Pyriproxyfen LLIN

Experimental group

Description:

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.

Treatment:

Other: pyriproxyfen LLIN

Chlorfenapyr LLIN

Experimental group

Description:

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.

Treatment:

Other: Chlorfenapyr LLIN

Piperonyl butoxide LLIN

Experimental group

Description:

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.

Treatment:

Other: Piperonyl butoxide LLIN

Standard LLIN

Active Comparator group

Description:

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.

Treatment:

Other: Standard LLIN