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Clinical Evaluation of Mosquito Coils to Control Malaria in China

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Yunnan Institute
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00442442
First received: March 1, 2007
Last updated: October 30, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
Malaria
 Device: mosquito coils
Device: LLIN
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Mosquito Coils to Control Malaria in China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

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

Secondary Outcome Measures:
  • Fever reports [ Time Frame: 6 months ]
  • User acceptance [ Time Frame: 6 months ]
  • entomological data [ Time Frame: 6 months ]

Estimated Enrollment: 8000
Study Start Date: April 2007
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not sleeping at home each night
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442442

Locations
China, Yunnan
Yunnan Institute of Parasitic Diseases
Simao, Yunnan, China, 65000
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Yunnan Institute
Investigators
Principal Investigator: Nigel Hill, PhD LSHTM
Principal Investigator: Hong Ning Zhou, MSc Yunnan Institute of Parasitic Diseases
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00442442     History of Changes
Other Study ID Numbers: IDCVNHIL01, LSHTM ITDCVP89
Study First Received: March 1, 2007
Last Updated: October 30, 2007
Health Authority: China: Ministry of Health

Keywords provided by London School of Hygiene and Tropical Medicine:
Malaria
mosquito control
mosquito coils
LLIN

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 23, 2013