Condition category
Infections and Infestations
Date applied
23/07/2012
Date assigned
07/09/2012
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dengue is a common viral infection spread by mosquitoes. It is widespread in tropical and sub-tropical regions, mainly affecting urban areas but extending into more populated rural areas. The mosquitoes breed in water storage containers and other deposits containing relatively clean water. Attempts at eradicating the mosquitoes failed during the 1960s in Latin America and today more than 50% of houses are infested with mosquitoes in many endemic areas. This research is studying new methods to control dengue mosquitoes. We are studying the acceptance, effectiveness and cost-effectiveness of insecticide-treated curtains and of spraying the insecticide deltamethrin in and around the house.

Who can participate?
Houseblocks are selected at random in the city of Santiago de Cuba among those with the highest infestation rates in 2009-2010, and all families living in these areas are invited to participate

What does the study involve?
Groups of houses are randomly allocated to one of three groups. Group 1 receive the routine mosquito control activities of the Ministry of Health programme. Group 2 receive insecticide-treated curtains (maximum of three per house) on top of the routine mosquito control activities of the Ministry of Health programme. Group 3 receive every four months a spraying of deltamethrin in and around their houses on top of the routine mosquito control activities of the Ministry of Health programme.

What are the possible benefits and risks of participating?
Participants receive the mosquito control methods for free. As they have shown already good results in other studies, the mosquitoes in the house will decrease if the tool is correctly used. The curtains that will be distributed didn’t show any side effects in other studies, except for a brief feeling of itching and sneezing in 7% of the people, lasting for at most 1 day. The spraying is a procedure that has already been used in Santiago de Cuba by the Ministry of Health. In this study it’s another insecticide, widely used in Africa and Latin-America, but up to now not yet used in this area in this form.

Where is the study run from?
Institute of Tropical Medicine (Belgium)

When is the study starting and how long is it expected to run for?
May 2011 to December 2013

Who is funding the study?
1. Directorate-General for Development Cooperation (Belgium)
2. Institute of Tropical Medicine (Belgium)
3. Ministry of Health (Cuba)

Who is the main contact?
Prof. Patrick Van der Stuyft

Trial website

Contact information

Type

Scientific

Primary contact

Prof Patrick Van der Stuyft

ORCID ID

Contact details

Institute of Tropical Medicine
General Epidemiology and Disease Control
Public Health Department
Nationalestraat 155
Anwterp
2000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B300201111923

Study information

Scientific title

Effectiveness and cost-effectiveness of perifocal residual deltamethrin spraying and of long lasting deltamethrin treated curtains distribution for Aedes control

Acronym

Study hypothesis

1. Evaluate the uptake and acceptability of tools in both intervention arms (ITC and PFS)
2. Evaluate the effectiveness of both tools, on top of the routine, in the control of Aedes aegypti (in comparison to the effect of the routine programme alone)
3. Compare the cost-effectiveness of both tools with the routine Aedes control strategy

Ethics approval

Ethical Committee, University Hospital Antwerp, 14/11/2011 ref: 11/34/227

Study design

Interventional cluster-randomized controlled trial single-center study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Effect of intervention on Aedes aegypti infestation level (vector of dengue fever)

Intervention

Control group: routine aedes control programme (entomological surveillance, source reduction, larviciding and selectiveadulticiding, health education)

Insecticide treated curtains: made from long-lasting, insecticide-treated (pyrethroid deltamethrin is applied during manufacture) polyester netting that requires no re-impregnation (PermaNet®; Vestergaard-Frandsen company). PermaNet materials are special UV protected and retain their insecticidal properties and efficacy for about 2 years (information from producer). The material has been approved by WHOPES for use as bednets.

Deltamethrin perifocal spraying (PFS): K-Othrine 25 WG, supplied by Bayer Environmental Sciences co. (25% deltamethrin formulation) will be sprayed every 4 months (3 times/year). It is a granular formulation that need to be solved into water (20 gram in 8 Liter of water, sufficient to treat 200 m² and attaining 25 mg a.i./m²). It has a long lasting residual activity. Where deposits remain undisturbed, residual activity depends upon the nature of the surface. Sustained residual activity beyond 12 weeks post-application is observed on non-porous surfaces. Deltamethrin is photostable and the particulate suspension enhances availability to insects.

The insecticide will be sprayed on the outside of the ground-level water tanks and the walls behind them; and on the adult Aedes resting sites (for example under beds, in and under closets) in the intradomestic area.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Effectiveness: Breteau Index (number of containers positive for immature aedes stages per 100 inspected houses)
2. House index (number of houses positive for at least one container with aedes immature stages per 100 houses inspected)
3. Pupae per person index (number of pupae per inhabitant), (adult mosquito infestation), confirmed Dengue cases (if any)

Secondary outcome measures

1. Uptake and use of ITC
2. Acceptance of PFS and ITC (and identification of underlying lay dimensions of acceptability)
3. Change in intra-and extradomiciliary risks for Aedes infestation
4. Cost- effectiveness of ITC and of PFS
5. Residual insecticidal activity of deltamethrin applied in ITC and in PFS

Overall trial start date

01/05/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All households of houseblocks, chosen at random in urban Santiago de Cuba

Participant type

All

Age group

All

Gender

Both

Target number of participants

63 clusters of 250 households each

Participant exclusion criteria

1. Houseblocks without community approval
2. Houses without household approval

Recruitment start date

01/05/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Cuba

Trial participating centre

Institute of Tropical Medicine
Anwterp
2000
Belgium

Sponsor information

Organisation

Institute of Tropical Medicine (Belgium)

Sponsor details

General Epidemiology and Disease Control
Public Health Department
Nationalestraat 155
Antwerp
2000
Belgium

Sponsor type

University/education

Website

http://www.itg.be/itg/

Funders

Funder type

Government

Funder name

Directorate-General for Development Cooperation (Belgium) ref: 95900

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Tropical Medicine (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministerio de Salud Púšblica [MINSAP] (Cuba)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/08/2016: Plain English summary added.