search
Back to results

The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
Indoor residual spraying with bendiocarb
LLIN by universal coverage campaign
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring vector control, LLIN, IRS

Eligibility Criteria

6 Months - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • resident in selected cluster (village)

Exclusion Criteria:

  • Not resident in selected cluster (village)

Sites / Locations

  • PAMVERC officeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LLIN plus IRS

LLIN only

Arm Description

LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide

LLIN by universal coverage campaign

Outcomes

Primary Outcome Measures

Prevalence of malarial infection in children 6 months to 10 years

Secondary Outcome Measures

Moderate to severe anaemia in children under 5 years
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years

Full Information

First Posted
September 21, 2012
Last Updated
October 2, 2012
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
search

1. Study Identification

Unique Protocol Identification Number
NCT01697852
Brief Title
The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
Official Title
Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS. Findings from this study are expected to inform decision making so that resource utilization can be optimised.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
vector control, LLIN, IRS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LLIN plus IRS
Arm Type
Experimental
Arm Description
LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide
Arm Title
LLIN only
Arm Type
Active Comparator
Arm Description
LLIN by universal coverage campaign
Intervention Type
Other
Intervention Name(s)
Indoor residual spraying with bendiocarb
Other Intervention Name(s)
Ficam
Intervention Description
2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
Intervention Type
Other
Intervention Name(s)
LLIN by universal coverage campaign
Other Intervention Name(s)
Olyset nets
Intervention Description
Long lasting Insecticide treated mosquito net
Primary Outcome Measure Information:
Title
Prevalence of malarial infection in children 6 months to 10 years
Time Frame
9 months post randomisation
Secondary Outcome Measure Information:
Title
Moderate to severe anaemia in children under 5 years
Time Frame
9 months post randomisation
Title
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
Time Frame
6 months post randomisation
Other Pre-specified Outcome Measures:
Title
Entomological Innoculation Rate
Time Frame
Malaria season post randomisation(Average value during 6 months after randomisation)
Title
Relative abundance of adult Anopheles mosquitoes by species
Time Frame
Malaria season post randomisation (Average value during 6 months after randomisation)
Title
genotypic markers of insecticide resistance in malaria vector mosquitoes
Time Frame
Malaria season post randomisation (Average value during 6 months after randomisation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: resident in selected cluster (village) Exclusion Criteria: Not resident in selected cluster (village)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Rowland, PHD
Email
Mark.Rowland@lshtm.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Immo Kleinschmidt, PHD
Email
Immo.Kleinschmidt@lshtm.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Rowland, PHD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Immo Kleinschmidt, PHD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAMVERC office
City
Muleba
State/Province
Kagera
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha Protopopoff, PHD
Email
nprotopopoff@gmail.com
First Name & Middle Initial & Last Name & Degree
Natacha Protopopoff, PHD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19706925
Citation
Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
Results Reference
background
PubMed Identifier
22882836
Citation
West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.
Results Reference
result
PubMed Identifier
25811379
Citation
West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Enhanced protection against malaria by indoor residual spraying in addition to insecticide treated nets: is it dependent on transmission intensity or net usage? PLoS One. 2015 Mar 26;10(3):e0115661. doi: 10.1371/journal.pone.0115661. eCollection 2015.
Results Reference
derived
PubMed Identifier
24736370
Citation
West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.
Results Reference
derived

Learn more about this trial

The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention

We'll reach out to this number within 24 hrs