Clinical Evaluation of Mosquito Coils to Control Malaria in China
Primary Purpose
Malaria
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
mosquito coils
LLIN
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Malaria, mosquito control, mosquito coils, LLIN
Eligibility Criteria
Inclusion Criteria:
- 6 years plus,
- No allergy to products in use,
- Not pregnant / breast feeding
Exclusion Criteria:
- Not sleeping at home each night
Sites / Locations
- Yunnan Institute of Parasitic Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
No treatment control
LLIN Nets
Mosquito Coils
Mosquito coils & LLIN
Outcomes
Primary Outcome Measures
Malaria cases
Secondary Outcome Measures
Fever reports
User acceptance
entomological data
Full Information
NCT ID
NCT00442442
First Posted
March 1, 2007
Last Updated
October 30, 2007
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Yunnan Institute
1. Study Identification
Unique Protocol Identification Number
NCT00442442
Brief Title
Clinical Evaluation of Mosquito Coils to Control Malaria in China
Official Title
Clinical Evaluation of Mosquito Coils to Control Malaria in China
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Yunnan Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although mosquito coils are widely used, there is no robust evidence that their use can provide clinical reduction in malaria. This study will randomise 4 groups of 400 houses, each with 5 people, in rural China and monitor cases of malaria in each group each month for 6 months. The treatment groups will include Coils, Treated bed nets, Coils plus treated bed nets, or no treatment (control). All cases detected will be given prompt appropriate treatment.
Detailed Description
Mosquito coils are extremely widely used by households across the world and reportedly make up the largest single family expenditure on any health-related items in many developing Countries. Despite their widespread use there has been no robust clinical evaluation to determine whether they can provide protection from malaria. This study is designed to determine if using coils (and / or LLIN) each evening can reduce malaria at the household level.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, mosquito control, mosquito coils, LLIN
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No treatment control
Arm Title
2
Arm Type
Active Comparator
Arm Description
LLIN Nets
Arm Title
3
Arm Type
Experimental
Arm Description
Mosquito Coils
Arm Title
4
Arm Type
Experimental
Arm Description
Mosquito coils & LLIN
Intervention Type
Device
Intervention Name(s)
mosquito coils
Intervention Description
mosquito coil / night mosquito coil & LLIN / night
Intervention Type
Device
Intervention Name(s)
LLIN
Intervention Description
Sleep under LLIN every night
Primary Outcome Measure Information:
Title
Malaria cases
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fever reports
Time Frame
6 months
Title
User acceptance
Time Frame
6 months
Title
entomological data
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
6 years plus,
No allergy to products in use,
Not pregnant / breast feeding
Exclusion Criteria:
Not sleeping at home each night
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Hill, PhD
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Ning Zhou, MSc
Organizational Affiliation
Yunnan Institute of Parasitic Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yunnan Institute of Parasitic Diseases
City
Simao
State/Province
Yunnan
ZIP/Postal Code
65000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24885993
Citation
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.
Results Reference
derived
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Clinical Evaluation of Mosquito Coils to Control Malaria in China
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