NCT01697852

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22,300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

September 21, 2012

Last Update Submit

October 2, 2012

Conditions

Keywords

vector controlLLINIRS

Outcome Measures

Primary Outcomes (1)

  • Prevalence of malarial infection in children 6 months to 10 years

    9 months post randomisation

Secondary Outcomes (2)

  • Moderate to severe anaemia in children under 5 years

    9 months post randomisation

  • Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years

    6 months post randomisation

Other Outcomes (3)

  • Entomological Innoculation Rate

    Malaria season post randomisation(Average value during 6 months after randomisation)

  • Relative abundance of adult Anopheles mosquitoes by species

    Malaria season post randomisation (Average value during 6 months after randomisation)

  • genotypic markers of insecticide resistance in malaria vector mosquitoes

    Malaria season post randomisation (Average value during 6 months after randomisation)

Study Arms (2)

LLIN plus IRS

EXPERIMENTAL

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

Other: Indoor residual spraying with bendiocarbOther: LLIN by universal coverage campaign

LLIN only

ACTIVE COMPARATOR

LLIN by universal coverage campaign

Other: LLIN by universal coverage campaign

Interventions

2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart

Also known as: Ficam
LLIN plus IRS

Long lasting Insecticide treated mosquito net

Also known as: Olyset nets
LLIN onlyLLIN plus IRS

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • resident in selected cluster (village)

You may not qualify if:

  • Not resident in selected cluster (village)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAMVERC office

Muleba, Kagera, Tanzania

RECRUITING

Related Publications (4)

  • 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.

    PMID: 19706925BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Malaria

Interventions

bendiocarb

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Mark Rowland, PHD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Immo Kleinschmidt, PHD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Rowland, PHD

CONTACT

Immo Kleinschmidt, PHD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 2, 2012

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations