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Clinical Evaluation of Mosquito Coils to Control Malaria in China

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. Identifier: NCT00442442
Recruitment Status : Unknown
Verified October 2007 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2007
Last Update Posted : October 31, 2007
Yunnan Institute
Information provided by:
London School of Hygiene and Tropical Medicine

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.

Condition or disease Intervention/treatment Phase
Malaria Device: mosquito coils Device: LLIN Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Mosquito Coils to Control Malaria in China
Study Start Date : April 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
No treatment control
Active Comparator: 2
Device: LLIN
Sleep under LLIN every night

Experimental: 3
Mosquito Coils
Device: mosquito coils
mosquito coil / night mosquito coil & LLIN / night

Experimental: 4
Mosquito coils & LLIN
Device: mosquito coils
mosquito coil / night mosquito coil & LLIN / night

Primary Outcome Measures :
  1. Malaria cases [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Fever reports [ Time Frame: 6 months ]
  2. User acceptance [ Time Frame: 6 months ]
  3. entomological data [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 6 years plus,
  • No allergy to products in use,
  • Not pregnant / breast feeding

Exclusion Criteria:

  • Not sleeping at home each night

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 identifier (NCT number): NCT00442442

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China, Yunnan
Yunnan Institute of Parasitic Diseases
Simao, Yunnan, China, 65000
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Yunnan Institute
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Principal Investigator: Nigel Hill, PhD LSHTM
Principal Investigator: Hong Ning Zhou, MSc Yunnan Institute of Parasitic Diseases
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00442442    
Other Study ID Numbers: IDCVNHIL01
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by London School of Hygiene and Tropical Medicine:
mosquito control
mosquito coils
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases