The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
This study is currently recruiting participants.
Verified October 2012 by London School of Hygiene and Tropical Medicine
Sponsor:
London School of Hygiene and Tropical Medicine
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
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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
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
Additional 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 May 16, 2013