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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2012 by London School of Hygiene and Tropical Medicine.
Recruitment status was: Recruiting

Sponsor:

Collaborators:

National Institute for Medical Research, Tanzania

Kilimanjaro Christian Medical Centre, Tanzania

Information provided by (Responsible Party):

London School of Hygiene and Tropical Medicine

ClinicalTrials.gov Identifier:

NCT01697852

First received: September 21, 2012

Last updated: October 2, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Malaria	Other: Indoor residual spraying with bendiocarb Other: LLIN by universal coverage campaign	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

Prevalence of malarial infection in children 6 months to 10 years [ Time Frame: 9 months post randomisation ]

Secondary Outcome Measures:

Moderate to severe anaemia in children under 5 years [ Time Frame: 9 months post randomisation ]
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years [ Time Frame: 6 months post randomisation ]

Other Outcome Measures:

Entomological Innoculation Rate [ Time Frame: Malaria season post randomisation(Average value during 6 months after randomisation) ]
Relative abundance of adult Anopheles mosquitoes by species [ Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation) ]
genotypic markers of insecticide resistance in malaria vector mosquitoes [ Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation) ]


Estimated Enrollment:	22300
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LLIN plus IRS LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide	Other: Indoor residual spraying with bendiocarb 2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart Other Name: Ficam Other: LLIN by universal coverage campaign Long lasting Insecticide treated mosquito net Other Name: Olyset nets
Active Comparator: LLIN only LLIN by universal coverage campaign	Other: LLIN by universal coverage campaign Long lasting Insecticide treated mosquito net Other Name: Olyset nets

Eligibility


Ages Eligible for Study:	6 Months to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

resident in selected cluster (village)

Exclusion Criteria:

Not resident in selected cluster (village)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697852

Contacts


Contact: Mark Rowland, PHD		Mark.Rowland@lshtm.ac.uk
Contact: Immo Kleinschmidt, PHD		Immo.Kleinschmidt@lshtm.ac.uk

Locations


Tanzania
PAMVERC office	Recruiting
Muleba, Kagera, Tanzania
Contact: Natacha Protopopoff, PHD nprotopopoff@gmail.com
Principal Investigator: Natacha Protopopoff, PHD

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

National Institute for Medical Research, Tanzania

Kilimanjaro Christian Medical Centre, Tanzania

Investigators


Principal Investigator:	Mark Rowland, PHD	London School of Hygiene and Tropical Medicine
Principal Investigator:	Immo Kleinschmidt, PHD	London School of Hygiene and Tropical Medicine

More Information

Publications:

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.

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT01697852 History of Changes
Other Study ID Numbers:	ITDCVP54
Study First Received:	September 21, 2012
Last Updated:	October 2, 2012

Keywords provided by London School of Hygiene and Tropical Medicine:


vector control LLIN IRS

Additional relevant MeSH terms:


Malaria Protozoan Infections Parasitic Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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