Overview

This trial is active, not recruiting.

Condition malaria
Treatments mosquito coils, llin
Phase phase 3
Sponsor London School of Hygiene and Tropical Medicine
Collaborator Yunnan Institute
Start date April 2007
End date December 2007
Trial size 8000 participants
Trial identifier NCT00442442, IDCVNHIL01, LSHTM ITDCVP89

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
No treatment control
(Active Comparator)
LLIN Nets
llin
Sleep under LLIN every night
(Experimental)
Mosquito Coils
mosquito coils
mosquito coil / night mosquito coil & LLIN / night
(Experimental)
Mosquito coils & LLIN
mosquito coils
mosquito coil / night mosquito coil & LLIN / night

Primary Outcomes

Measure
Malaria cases
time frame: 6 months

Secondary Outcomes

Measure
Fever reports
time frame: 6 months
User acceptance
time frame: 6 months
entomological data
time frame: 6 months

Eligibility Criteria

Male or female participants at least 6 years old.

Inclusion Criteria: - 6 years plus, - No allergy to products in use, - Not pregnant / breast feeding Exclusion Criteria: - Not sleeping at home each night

Additional Information

Official title Clinical Evaluation of Mosquito Coils to Control Malaria in China
Principal investigator Nigel Hill, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.