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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by London School of Hygiene and Tropical Medicine
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
  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
Endpoint Classification: Efficacy Study
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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Moderate to severe anaemia in children under 5 years [ Time Frame: 9 months post randomisation ] [ Designated as safety issue: No ]
  • Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years [ Time Frame: 6 months post randomisation ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Entomological Innoculation Rate [ Time Frame: Malaria season post randomisation(Average value during 6 months after randomisation) ] [ Designated as safety issue: No ]
  • Relative abundance of adult Anopheles mosquitoes by species [ Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation) ] [ Designated as safety issue: No ]
  • genotypic markers of insecticide resistance in malaria vector mosquitoes [ Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation) ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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:
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
Health Authority: Tanzania: National Institute for Medical Research

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 October 01, 2014