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

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ClinicalTrials.gov Identifier: NCT01663831
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : February 3, 2014
Sponsor:
Collaborators:
NCHADS - Ministry of Health of Cambodia
Institut Pasteur
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Brief Summary:

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 or disease Intervention/treatment Phase
Malaria Other: Mosquito topical repellent Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from baseline in malaria prevalence at 6 months [ Time Frame: 6 months ]
    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 :
  1. Malaria incidence [ Time Frame: 6 months ]
    Through passive RDT case detection



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All household members volunteering from selected communities

Exclusion Criteria:

  • Infants less than 2 years

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): 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

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
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

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
Protozoan Infections
Parasitic Diseases