Clinical Evaluation of Mosquito Coils to Control Malaria in China

NCT ID: NCT00442442

Last Updated: 2007-10-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Malaria

Keywords

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Malaria mosquito control mosquito coils LLIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

No treatment control

Group Type NO_INTERVENTION

No interventions assigned to this group

2

LLIN Nets

Group Type ACTIVE_COMPARATOR

LLIN

Intervention Type DEVICE

Sleep under LLIN every night

3

Mosquito Coils

Group Type EXPERIMENTAL

mosquito coils

Intervention Type DEVICE

mosquito coil / night mosquito coil \& LLIN / night

4

Mosquito coils \& LLIN

Group Type EXPERIMENTAL

mosquito coils

Intervention Type DEVICE

mosquito coil / night mosquito coil \& LLIN / night

Interventions

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mosquito coils

mosquito coil / night mosquito coil \& LLIN / night

Intervention Type DEVICE

LLIN

Sleep under LLIN every night

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not sleeping at home each night
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yunnan Institute

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

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

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 24885993 (View on PubMed)

Other Identifiers

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LSHTM ITDCVP89

Identifier Type: -

Identifier Source: secondary_id

IDCVNHIL01

Identifier Type: -

Identifier Source: org_study_id