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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01697852
• Other study ID #: ITDCVP54
• Status: Unknown status
• Phase: Phase 4
• First received: September 21, 2012
• Last updated: October 2, 2012
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: London School of Hygiene and Tropical Medicine
• Contact: Mark Rowland, PHD
• Email: Mark.Rowland[@]lshtm.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 22300
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 14 Years

Eligibility

Inclusion Criteria:

• resident in selected cluster (village)

Exclusion Criteria:

• Not resident in selected cluster (village)

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• Indoor residual spraying with bendiocarb
2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
• LLIN by universal coverage campaign
Long lasting Insecticide treated mosquito net

Locations

Country	Name	City	State
Tanzania	PAMVERC office	Muleba	Kagera

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Kilimanjaro Christian Medical Centre, Tanzania, National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Entomological Innoculation Rate		Malaria season post randomisation(Average value during 6 months after randomisation)
Other	Relative abundance of adult Anopheles mosquitoes by species		Malaria season post randomisation (Average value during 6 months after randomisation)
Other	genotypic markers of insecticide resistance in malaria vector mosquitoes		Malaria season post randomisation (Average value during 6 months after randomisation)
Primary	Prevalence of malarial infection in children 6 months to 10 years		9 months post randomisation
Secondary	Moderate to severe anaemia in children under 5 years		9 months post randomisation
Secondary	Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years		6 months post randomisation