Repellents as Added Control Measure to Long Lasting Insecticidal Nets (MalaResT)

This study has been completed.
Sponsor:
Collaborators:
NCHADS - Ministry of Health of Cambodia
Institut Pasteur
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT01663831
First received: July 17, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these control methods tackle only indoor and night biting vectors. The proportion of transmission occurring outdoors and before sleeping hours or so-called "residual transmission" is steadily increasing and may compromise the effort towards malaria elimination.

The purpose of this study is to raise evidence on the effectiveness of mass use of topical repellents in addition to LLINs in controlling malaria infections.

A multidisciplinary approach will be used to collect information on the most important factors that contribute to the successful reduction of "residual malaria transmission". In a first objective the epidemiological efficacy of repellents on prevalence of malaria carriers and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross sectional random sample of 65 people will be drawn at the beginning and the end of the malaria season to obtain an estimate of the malaria prevalence. The second objective will handle the entomological efficacy and persistence of the topical repellent on malaria vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will be studied in a third objective.


Condition Intervention
Malaria
Other: Mosquito topical repellent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Repellents as Added Control Measure to Long Lasting Insecticidal Nets to Target the Residual Transmission in Southeast Asia: a Step Forwards to Malaria Elimination

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Change from baseline in malaria prevalence at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Malaria prevalence (PCR detection) will be measured in both study arms at the start and end of the malaria season for 2 consecutive years.


Secondary Outcome Measures:
  • Malaria incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Through passive RDT case detection


Enrollment: 40000
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical Repellent & LLIN Other: Mosquito topical repellent
Daily repellent use, before and after sleeping hours during the malaria season (6 months) in addition to the use of Long Lasting Insecticidal Nets during sleeping hours.
Other Names:
  • Brand name: Autan
  • Active ingredient: Icaridin
No Intervention: Long Lasting Insecticidal Nets

Brand Name LLIN: Olyset Net

Active ingredient: permethrin


  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All household members volunteering from selected communities

Exclusion Criteria:

  • Infants less than 2 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01663831

Locations
Cambodia
Banlung, Ratanakiri, Cambodia
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
NCHADS - Ministry of Health of Cambodia
Institut Pasteur
Investigators
Principal Investigator: Marc Coosemans, Professor Institute of Tropical Medicine Antwerp
  More Information

No publications provided by Institute of Tropical Medicine, Belgium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT01663831     History of Changes
Other Study ID Numbers: OPP1032354
Study First Received: July 17, 2012
Last Updated: January 31, 2014
Health Authority: Cambodia: Ministry of Health
Belgium: Ethics Committee
Belgium: Institutional Review Board

Keywords provided by Institute of Tropical Medicine, Belgium:
Outdoor Malaria Transmission
Anopheles
Topical repellent
Early biting vector
Long Lasting Insecticidal Net (LLIN)
Cambodia

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 20, 2014