NCT01663831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

July 17, 2012

Last Update Submit

May 9, 2025

Conditions

Malaria

Keywords

Outdoor Malaria TransmissionAnophelesTopical repellentEarly biting vectorLong Lasting Insecticidal Net (LLIN)Cambodia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in malaria prevalence at 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.

    6 months

Secondary Outcomes (1)

  • Malaria incidence

    6 months

Study Arms (2)

Topical Repellent & LLIN

EXPERIMENTAL
Other: Mosquito topical repellent

Long Lasting Insecticidal Nets

NO INTERVENTION

Brand Name LLIN: Olyset Net Active ingredient: permethrin

Interventions

Mosquito topical repellentOTHER

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.

Also known as: Brand name: Autan, Active ingredient: Icaridin
Topical Repellent & LLIN

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All household members volunteering from selected communities

You may not qualify if:

  • Infants less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Banlung, Ratanakiri, Cambodia

Location

Related Publications (3)

  • Sluydts V, Durnez L, Heng S, Gryseels C, Canier L, Kim S, Van Roey K, Kerkhof K, Khim N, Mao S, Uk S, Sovannaroth S, Grietens KP, Sochantha T, Menard D, Coosemans M. Efficacy of topical mosquito repellent (picaridin) plus long-lasting insecticidal nets versus long-lasting insecticidal nets alone for control of malaria: a cluster randomised controlled trial. Lancet Infect Dis. 2016 Oct;16(10):1169-1177. doi: 10.1016/S1473-3099(16)30148-7. Epub 2016 Jun 29.

    PMID: 27371977DERIVED

  • Heng S, Durnez L, Gryseels C, Van Roey K, Mean V, Uk S, Siv S, Grietens KP, Sochantha T, Coosemans M, Sluydts V. Assuring access to topical mosquito repellents within an intensive distribution scheme: a case study in a remote province of Cambodia. Malar J. 2015 Nov 24;14:468. doi: 10.1186/s12936-015-0960-4.

    PMID: 26597653DERIVED

  • Canier L, Khim N, Kim S, Sluydts V, Heng S, Dourng D, Eam R, Chy S, Khean C, Loch K, Ken M, Lim H, Siv S, Tho S, Masse-Navette P, Gryseels C, Uk S, Van Roey K, Grietens KP, Sokny M, Thavrin B, Chuor CM, Deubel V, Durnez L, Coosemans M, Menard D. An innovative tool for moving malaria PCR detection of parasite reservoir into the field. Malar J. 2013 Nov 9;12:405. doi: 10.1186/1475-2875-12-405.

    PMID: 24206649DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Marc Coosemans, Professor

    Institute of Tropical Medicine Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

August 13, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations

CA(1)