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ISRCTN
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ISRCTN03844341
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial to assess the LifeStraw® Family household gravity filter
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The objectives of the study are:
1. To assess the effectiveness of the LifeStraw® Family household filter in preventing diarrhoeal diseases
2. To determine the effectiveness of the LifeStraw® household filter in reducing the bacterial load of drinking water
3. To evaluate the extent to which it is used correctly and consistently by, and is acceptable to, the target population
4. We will also measure longevity of the filter as it is used in a field setting
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Ethics approval
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Ethics approval received from:
1. The London School of Hygiene and Tropical Medicine (LSHTM) Ethics Board on the 15th November 2007 (ref: 5206)
2. Ecole de sante publique, Democratic Republic of Congo on the 22nd January 2008 (ref: ESP/CE/004/2008)
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Study design
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Two-armed randomised placebo-controlled trial
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Countries of recruitment
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Democratic Republic of Congo
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Disease/condition/study domain
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Diarrhoea
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Participants - inclusion criteria
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Households including members of all ages living in the study communities.
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Participants - exclusion criteria
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Households and individuals who treat their water in a way that is deemed effective to prevent diarrhoea (e.g. boiling, filtration with a state of the art filter, regular use of bleach).
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Anticipated start date
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01/06/2008
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Anticipated end date
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30/06/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information
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Target number of participants
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240 households with around 1200 participants
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Interventions
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A two-arm randomised placebo-controlled trial will be conducted over a 12-month period. The trial will include two groups of households: half of the participating households will receive the LifeStraw® filter and the other half will receive a filter which looks like the LifeStraw® filter but which does not remove pathogens from the water.
The placebo has the same outside components as the real filter but the filtering membranes inside the cartridge have been replaced by some extra piping to imitate the weight of the real cartridge and the flow coming out of it.
Within one month of distributing the filters, field investigators will visit each household once a month (i.e. 12 visits per household during the overall follow-up period) to conduct a health survey. They will record for each household member, whether she/he had experienced any illness in the past 7 days, prompting a list of symptoms - in which diarrhoea is included - if no answer was spontaneously given.
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Primary outcome measure(s)
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Diarrhoea longitudinal prevalence, measured as weekly period prevalence.
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Secondary outcome measure(s)
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1. Use of device, measured every month
2. Bacterial load reduction in drinking water, measured every month
3. Acceptability, measured once at the end of the study
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Sources of funding
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Vestergaard Frandsen (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Thomas
Clasen
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Address
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DCVBU
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Email
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Thomas.Clasen@lshtm.ac.uk
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Sponsor
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Vestergaard Frandsen (Switzerland)
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Address
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Head Office - Switzerland
Chemin de Messidor 5 - 7
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City/town
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Lausanne
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Zip/Postcode
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CH-1006
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Country
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Switzerland
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Tel
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+41 (0)21 310 7333
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Fax
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+41 (0)21 310 7330
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Email
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info@vestergaard-frandsen.com
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Sponsor website:
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http://www.vestergaard-frandsen.com/
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Date applied
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20/05/2008
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Last edited
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12/06/2008
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Date ISRCTN assigned
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12/06/2008
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