Clinical Evaluation of Mosquito Coils to Control Malaria in China
NCT ID: NCT00442442
Last Updated: 2007-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
8000 participants
INTERVENTIONAL
2007-04-30
2007-12-31
Brief Summary
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Detailed Description
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The study will be a single-blind, randomised clinical evaluation clustered at the household level. There will be 4 treatment arms, Coils / Insecticide treated nets / Coils + ITN / No treatment. Each arm will include 400 households each with 5 people / household (total of 8000 people). A maximum of 20% of houses in any village will be enrolled to reduce any effects of diversion of mosquitoes by any treatment. Epidemiological factors and baseline malaria prevalence will be recorded during a pre-intervention baseline month by questionnaire and rapid diagnostic test (RDT) using species-specific dip sticks for malaria. Post intervention will be 5 further monthly visits during the malaria season to detect new cases by RDT, reported fevers and operational data (compliance, adverse effects etc). Primary outcome clinical measures will be incidence of malaria (P. falciparum / P. vivax) comparing new cases in each of the 3 treatment \& non-treatment groups. All cases will be treated promptly according to local policy. At the end of the study, all households which did not have a treated bed net will be provided with one.
Secondary non-clinical outcome measures will include entomological data collected in houses using / non using coils in sentinel villages at baseline \& during the study. CDC mosquito light traps will be used to record number / species / feeding status / parity (age) / sporozoite infection rates of mosquitoes in houses using / not-using coils following a randomised latin square design. Such entomological data can be used to determine reduction in vector species mosquitoes entering houses using coils and / or ITN.
Ethical approval for the study has been granted by the LSHTM University of London Ethics Committee and the Yunnan Bureau of Health, P.R.China.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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1
No treatment control
No interventions assigned to this group
2
LLIN Nets
LLIN
Sleep under LLIN every night
3
Mosquito Coils
mosquito coils
mosquito coil / night mosquito coil \& LLIN / night
4
Mosquito coils \& LLIN
mosquito coils
mosquito coil / night mosquito coil \& LLIN / night
Interventions
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mosquito coils
mosquito coil / night mosquito coil \& LLIN / night
LLIN
Sleep under LLIN every night
Eligibility Criteria
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Inclusion Criteria
* No allergy to products in use,
* Not pregnant / breast feeding
Exclusion Criteria
6 Years
ALL
Yes
Sponsors
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Yunnan Institute
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Principal Investigators
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Nigel Hill, PhD
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Hong Ning Zhou, MSc
Role: PRINCIPAL_INVESTIGATOR
Yunnan Institute of Parasitic Diseases
Locations
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Yunnan Institute of Parasitic Diseases
Pu'er, Yunnan, China
Countries
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References
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Hill N, Zhou HN, Wang P, Guo X, Carneiro I, Moore SJ. A household randomized, controlled trial of the efficacy of 0.03% transfluthrin coils alone and in combination with long-lasting insecticidal nets on the incidence of Plasmodium falciparum and Plasmodium vivax malaria in Western Yunnan Province, China. Malar J. 2014 May 31;13:208. doi: 10.1186/1475-2875-13-208.
Other Identifiers
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LSHTM ITDCVP89
Identifier Type: -
Identifier Source: secondary_id
IDCVNHIL01
Identifier Type: -
Identifier Source: org_study_id