Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01697852
Recruitment Status : Unknown
Verified October 2012 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Recruiting
First Posted : October 2, 2012
Last Update Posted : October 3, 2012
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence of malarial infection in children 6 months to 10 years [ Time Frame: 9 months post randomisation ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697852


Contacts
Layout table for location contacts
Contact: Mark Rowland, PHD Mark.Rowland@lshtm.ac.uk
Contact: Immo Kleinschmidt, PHD Immo.Kleinschmidt@lshtm.ac.uk

Locations
Layout table for location information
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

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

Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01697852     History of Changes
Other Study ID Numbers: ITDCVP54
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by London School of Hygiene and Tropical Medicine:
vector control
LLIN
IRS

Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases