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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin

Clinicaltrials.gov identifier NCT03931473

Recruitment Status Not yet recruiting

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

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 have been developed to control resistant mosquitoes. The efficacy of two bi-treated LLIN are compared to a standard LLIN in a three-arm, single blinded, cluster-randomized trial in Cove, Benin. 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/ The control arm: Interceptor, a standard LLIN treated with alpha-cypermethrin. The primary outcome of the trial will be malaria case incidence in children aged 6 months to 10 years.

  • Condition or Disease:Malaria
    Anemia
  • Intervention/Treatment: Other: Bed nets
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 1500 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin
  • Estimated Study Start Date: January 2020
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: July 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Interceptor
Alpha-cypermethrin
Other: Bed nets
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net
Experimental: Interceptor G2
Chlorfenapyr/alpha-cypermethrin
Other: Bed nets
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net
Experimental: Royal Guard
Pyriproxyfen/alpha-cypermethrin
Other: Bed nets
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net
Outcome Measures
  • Primary Outcome Measures: 1. Malaria Case Incidence [ Time Frame: 2 years ]
    Malaria case incidence in children aged 6 months to 10 years measured through bi-monthly/monthly visits
  • Secondary Outcome Measures: 1. Malaria Infection prevalence [ Time Frame: 18 months ]
    Malaria infection prevalence measured in cross-sectional surveys 6 months and 18 months post- distribution
  • 2. Entomological Inoculation Rate [ Time Frame: 2 years ]
Eligibility Criteria
  • Ages Eligible for Study: 6 Months and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria for cohort:

- Children aged 6 months to 9 years

- Resident in study villages

- Written, informed consent from guardians

Exclusion Criteria:

- Non-residents

Contacts and Locations
Contacts

Contact: Jackie Cook, PhD 02079272180 jackie.cook@lshtm.ac.uk

Locations
Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Centre de Recherche Entomologique de Cotonou

UNITAID

Innovative Vector Control Consortium

More Information
  • Responsible Party: London School of Hygiene and Tropical Medicine
  • ClinicalTrials.gov Identifier: NCT03931473 History of Changes
  • Other Study ID Numbers: NewNetsProject
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Malaria