Condition category
Infections and Infestations
Date applied
20/05/2008
Date assigned
12/06/2008
Last edited
23/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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The placebo has the same outside components as the real filter but the filtering membranes inside the cartridge have been replaced by some extra piping to imitate the weight of the real cartridge and the flow coming out of it.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 measures

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

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

http://www.vestergaard-frandsen.com/

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20856584

Publication citations

  1. 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.

Additional files

Editorial Notes