CClinicalTrials.gg
Status unknownNCT01697852Updated Oct 3, 2012

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

A Phase 4 interventional study of Indoor residual spraying with bendiocarb and LLIN by universal coverage campaign in Malaria, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Tanzania. Open to participants aged 6 Months to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-03.

Sponsored by London School of Hygiene and Tropical Medicine · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
22,300
Allocation
Randomized
Ages
6 Months to 14 Years
Sex
All
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Study 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.

02

Conditions studied

  • Malaria

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Keywords

  • vector control
  • LLIN
  • IRS
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's planned enrollment of 22,300 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • resident in selected cluster (village)

Exclusion criteria

Exclusion Criteria:

  • Not resident in selected cluster (village)
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22,300 participants (estimated)

Study arms

  • Experimental
    LLIN plus IRS

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

    Other: Indoor residual spraying with bendiocarb · Other: LLIN by universal coverage campaign

  • Active comparator
    LLIN only

    LLIN by universal coverage campaign

    Other: LLIN by universal coverage campaign

Interventions

  • OtherIndoor residual spraying with bendiocarb

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

    Also known as: Ficam

  • OtherLLIN by universal coverage campaign

    Long lasting Insecticide treated mosquito net

    Also known as: Olyset nets

06

What researchers measure

Primary outcomes

  1. Prevalence of malarial infection in children 6 months to 10 years

    Time frame: 9 months post randomisation

Secondary outcomes

  1. Moderate to severe anaemia in children under 5 years

    Time frame: 9 months post randomisation

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

    Time frame: 6 months post randomisation

Other outcomes

  1. Entomological Innoculation Rate

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

  2. Relative abundance of adult Anopheles mosquitoes by species

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

  3. genotypic markers of insecticide resistance in malaria vector mosquitoes

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

07

Study locations

1 of 1 sites recruiting
  • PAMVERC office
    Muleba, Kagera, Tanzania
    • Natacha Protopopoff, PHD · Contact · nprotopopoff@gmail.com
    • Natacha Protopopoff, PHD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19706925 ↗
  • 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. PubMed 22882836 ↗
  • 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. PubMed 25811379 ↗
  • 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. PubMed 24736370 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01697852
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Kilimanjaro Christian Medical Centre, Tanzania
Responsible party
Sponsor
First posted
Oct 2, 2012
Start date
Jan 2011
Primary completion
Nov 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Oct 3, 2012

Study contacts

Mark Rowland, PHD
Contact
Mark.Rowland@lshtm.ac.uk
Immo Kleinschmidt, PHD
Contact
Immo.Kleinschmidt@lshtm.ac.uk
Mark Rowland, PHD
principal investigator · London School of Hygiene and Tropical Medicine
Immo Kleinschmidt, PHD
principal investigator · London School of Hygiene and Tropical Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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