Contact information
Type
Scientific
Primary contact
Dr Thomas Clasen
ORCID ID
Contact details
DCVBU
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+ 44 (0)207 927 2916
Thomas.Clasen@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
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)
Study design
Two-armed randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information
Condition
Diarrhoea
Intervention
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The placebo has the same outside components as the real filter but the filtering membranes inside the cartridge have been replaced by some extra piping to imitate the weight of the real cartridge and the flow coming out of it.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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Diarrhoea longitudinal prevalence, measured as weekly period prevalence.
Secondary outcome measures
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
Overall trial start date
01/06/2008
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Households including members of all ages living in the study communities.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
240 households with around 1200 participants
Participant exclusion criteria
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).
Recruitment start date
01/06/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Congo, Democratic Republic
Trial participating centre
DCVBU
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Vestergaard Frandsen (Switzerland)
Sponsor details
Head Office - Switzerland
Chemin de Messidor 5 - 7
Lausanne
CH-1006
Switzerland
+41 (0)21 310 7333
info@vestergaard-frandsen.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Vestergaard Frandsen (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20856584
Publication citations
-
Results
Boisson S, Kiyombo M, Sthreshley L, Tumba S, Makambo J, Clasen T, Field assessment of a novel household-based water filtration device: a randomised, placebo-controlled trial in the Democratic Republic of Congo., PLoS ONE, 2010, 5, 9, e12613, doi: 10.1371/journal.pone.0012613.