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Trial record 5 of 10 for:    Pyrethrins

Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets

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ClinicalTrials.gov Identifier: NCT03554616
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
National Institute for Medical Research, Tanzania
University of Ottawa
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malaria Anaemia Other: Chlorfenapyr LLIN Other: pyriproxyfen LLIN Other: Piperonyl butoxide LLIN Other: Standard LLIN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Three Different Bi-treated Long Lasting Insecticidal Nets and Deployment Strategy for Control of Malaria Transmitted by Pyrethroid Resistant Vectors: A Randomised Controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 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.
Other: pyriproxyfen LLIN
Dual active ingredient Long Lasting Insecticidal Net

Experimental: 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.
Other: Chlorfenapyr LLIN
Dual active ingredient Long Lasting Insecticidal Net

Experimental: 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.
Other: Piperonyl butoxide LLIN
Combination insecticide and synergist Long Lasting Insecticidal Net

Active Comparator: 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.
Other: Standard LLIN
Standard Long Lasting Insecticidal Net with one insecticide




Primary Outcome Measures :
  1. Malaria infection prevalence in children 6 months to 14 years [ Time Frame: 12 months post intervention ]
    Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)

  2. Malaria infection prevalence in children 6 months to 14 years [ Time Frame: 24 months post intervention ]
    Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)


Secondary Outcome Measures :
  1. Incidence of malaria cases in children 6 months to 10 years [ Time Frame: Two years post intervention follow up ]
    Malaria incidence cases will be assessed using Malaria Rapid Diagnostic test (CareStart)

  2. Prevalence of anaemia in children under 5 years old [ Time Frame: 12, 18, 24 and 30 months post intervention ]
    Hemoglobin (Hb) concentration will be tested to assess anaemia (<8 g/dL) using HemoCue Hb 201+.

  3. Indoor Anopheles density [ Time Frame: Two years post intervention follow up ]
    Anopheles density per house per night will be assess every quarter in 8 houses per cluster using light trap. Anopheles density and sporozoite rate will be used to estimate the entomological inoculation rate (EIR)

  4. Sporozoite rate [ Time Frame: Two years post intervention follow up ]
    A sub-samples of Anopheles collected indoor will be tested for Plasmodium falciparum circumsporozoite protein using an ELISA test. Sporozoite rate will be used to estimate the EIR with Anopheles density.

  5. Insecticide content in Long Lasting Insecticidal Net (LLIN) [ Time Frame: at 0, 12, 24 and 30 months post intervention ]
    30 LLINs will be collected at yearly interval and Insecticide content in g/kg assessed with High-performance liquid chromatography (HPLC)

  6. Mortality in Anopheles after one hour exposure to every study LLIN [ Time Frame: at 0, 6, 12, 18, 24 and 30 months post intervention ]
    30 LLINs will be sampled every 6 months and tested in cone bio assay or tunnel test using resistant Anopheles and susceptible Kisumu Anopheles to assess for bio efficacy. 24, 48 and 72 hours mortality post exposure will be recorded.

  7. LLIN usage [ Time Frame: at 6, 12, 18, 24, 30 months post intervention ]
    The proportion of study participant declaring sleeping under a LLIN the previous night will be assessed during household survey every 6 months using a questionnaire.

  8. Malaria infection prevalence in children 6 months to 14 years [ Time Frame: 30 months post intervention ]
    Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)

  9. Malaria infection prevalence in children 6 months to 14 years [ Time Frame: 18 months post intervention ]
    Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)


Other Outcome Measures:
  1. Insecticide resistance intensity in wild Anopheles population [ Time Frame: Two years post intervention follow up ]
    Twice a year insecticide resistance will be assessed in wild Anopheles. 24 hours mortality will be recorded in Anopheles exposed to different concentrations of insecticides in CDC bottle assay or WHO test

  2. P450 over-expression in wild Anopheles population [ Time Frame: Two years post intervention follow up ]
    P450 genes involved in pyrethroid insecticide resistance will be monitored in the 4 arms once a year using reverse-transcription quantitative polymerase chain reaction (PCR)

  3. Frequency of Vgsc mutation in wild Anopheles population [ Time Frame: Two years post intervention follow up ]
    A sub sample of mosquitoes collected in the 4 arms will be tested for the Vgsc mutation involved in pyrethroid resistance using Taq Man PCR.

  4. Cost of each type of bi-treated LLIN [ Time Frame: Two years post intervention ]
    Cost of each intervention will be gathered and used to calculate cost per malaria case averted and cost per DALY averted



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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03554616


Contacts
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Contact: Frank W Mosha, Phd +255626316317 fwmosha@gmail.com
Contact: Alphaxard Manjurano, Phd +255756026661 amanjurano@yahoo.co.uk

Locations
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Tanzania
District Misungwi Recruiting
Misungwi, Mwanza, Tanzania
Contact: Jackie Mosha, MD, Phd         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Kilimanjaro Christian Medical Centre, Tanzania
National Institute for Medical Research, Tanzania
University of Ottawa
Investigators
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Principal Investigator: Natacha Protopopoff, Phd London School of Hygiene and Tropical Medicine

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03554616     History of Changes
Other Study ID Numbers: ITDCZN11
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in each publication will be shared and accessible in the LSHTM repository.
Supporting Materials: Study Protocol
Time Frame: The study protocol will be published
Access Criteria: open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by London School of Hygiene and Tropical Medicine:
Malaria
Vector Control
Long lasting Insecticidal Net

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases