Repellents as Added Control Measure to Long Lasting Insecticidal Nets

Malaria Clinical Trial

— MalaResT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663831
• Other study ID #: OPP1032354
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: January 31, 2014
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cambodia: Ministry of HealthBelgium: Ethics CommitteeBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40000
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• All household members volunteering from selected communities

Exclusion Criteria:

• Infants less than 2 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Institut Pasteur, NCHADS - Ministry of Health of Cambodia

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Malaria incidence	Through passive RDT case detection	6 months	No