Clinical Evaluation of Mosquito Coils to Control Malaria in China

October 30, 2007 updated by: London School of Hygiene and Tropical Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

8000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Simao, Yunnan, China, 65000
        • Yunnan Institute of Parasitic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not sleeping at home each night

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
No treatment control
ACTIVE_COMPARATOR: 2
LLIN Nets
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Malaria cases
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fever reports
Time Frame: 6 months
6 months
User acceptance
Time Frame: 6 months
6 months
entomological data
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Yunnan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (ANTICIPATED)

December 1, 2007

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (ESTIMATE)

March 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCVNHIL01
  • LSHTM ITDCVP89

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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