The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
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| ClinicalTrials.gov Identifier: NCT01697852 |
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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
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: LLIN plus IRS
LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide
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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 |
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Active Comparator: LLIN only
LLIN by universal coverage campaign
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Other: LLIN by universal coverage campaign
Long lasting Insecticide treated mosquito net
Other Name: Olyset nets |
- Prevalence of malarial infection in children 6 months to 10 years [ Time Frame: 9 months post randomisation ]
- 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 ]
- 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) ]
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| Ages Eligible for Study: | 6 Months to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- resident in selected cluster (village)
Exclusion Criteria:
- Not resident in selected cluster (village)
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
| Contact: Mark Rowland, PHD | Mark.Rowland@lshtm.ac.uk | ||
| Contact: Immo Kleinschmidt, PHD | Immo.Kleinschmidt@lshtm.ac.uk |
| Tanzania | |
| PAMVERC office | Recruiting |
| Muleba, Kagera, Tanzania | |
| Contact: Natacha Protopopoff, PHD nprotopopoff@gmail.com | |
| Principal Investigator: Natacha Protopopoff, PHD | |
| Principal Investigator: | Mark Rowland, PHD | London School of Hygiene and Tropical Medicine | |
| Principal Investigator: | Immo Kleinschmidt, PHD | London School of Hygiene and Tropical Medicine |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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vector control LLIN IRS |
Additional relevant MeSH terms:
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Malaria Protozoan Infections Parasitic Diseases |