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Clinical Evaluation of Mosquito Coils to Control Malaria in China

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Yunnan Institute
Information provided by:
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE March 1, 2007
First Posted Date  ICMJE March 2, 2007
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
Malaria cases [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2007)
Malaria cases
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
  • Fever reports [ Time Frame: 6 months ]
  • User acceptance [ Time Frame: 6 months ]
  • entomological data [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2007)
  • Fever reports
  • User acceptance
  • entomological data
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Mosquito Coils to Control Malaria in China
Official Title  ICMJE Clinical Evaluation of Mosquito Coils to Control Malaria in China
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE
  • Device: mosquito coils
    mosquito coil / night mosquito coil & LLIN / night
  • Device: LLIN
    Sleep under LLIN every night
Study Arms  ICMJE
  • No Intervention: 1
    No treatment control
  • Active Comparator: 2
    LLIN Nets
    Intervention: Device: LLIN
  • Experimental: 3
    Mosquito Coils
    Intervention: Device: mosquito coils
  • Experimental: 4
    Mosquito coils & LLIN
    Intervention: Device: mosquito coils
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 1, 2007)
8000
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Not sleeping at home each night
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442442
Other Study ID Numbers  ICMJE IDCVNHIL01
LSHTM ITDCVP89
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE Yunnan Institute
Investigators  ICMJE
Principal Investigator: Nigel Hill, PhD LSHTM
Principal Investigator: Hong Ning Zhou, MSc Yunnan Institute of Parasitic Diseases
PRS Account London School of Hygiene and Tropical Medicine
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP