Primary objective: To determine the dynamics of MRSA carriage in persons working on or living at pig and veal farms.Secondary objectives: To determine the amount of disease associated with carriage of MRSA-CC398. To determine the role of exposure to…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the prevalence of persistent MRSA carriage in primary
versus secondary exposed persons. A secondary case is defined as a household
member that carries MRSA-CC398 on a farm were MRSA was found during the study
period. Persistent carriage is defined as all samplings being positive for
MRSA, intermittent carriage is defined as 1 to 5 out of 6 samples positive. If
none of the samples return MRSA it is referred to as non-carriage. Adjustment
for factors that may influence persistent carriage, e.g. carriage of
methicillin susceptible S. aureus (MSSA), throat carriage, the amount of MRSA
present in the nose or throat and the presence of MRSA in wounds or skin
diseases will be done. Furthermore, the association between the number of
positive samples during the initial 3 swabs and the carriage status at 4, 8 and
12 months is determined. This is done for both MSSA and MRSA.
Secondary outcome
To determine the amount of disease associated with carriage of MRSA-CC398 the
occurrence of medical events will be recorded. Not only infections caused by
MRSA are included in this follow-up but also visits to the general
practitionar, use of antibiotics, hospital admissions etc. Adjustment for
factors that may affect the occurrence of disease will be done using regression
analysis. Lastly the exposure to dust on MRSA positive farms will be studied,
using information from questionnaires, personal dust samplers and environmental
samples from house and stable.
Background summary
Traditionally, methicillin-resistant Staphylococcus aureus (MRSA) has been
considered a hospital related pathogen. More recently, MRSA has emerged in the
community as well. Recently a specific clone, MRSA-CC398, has been discovered,
which is coming from an extensive animal reservoir. Initial surveys have shown
a high prevalence of carriage in livestock farmers (up to 30%) and lower
carriage rates in people living on farms but with limited direct contact with
the animals (up to 4%). MRSA has also been recovered from more than 10% of
retail pork and 16% of veal calf meat samples in The Netherlands. However, the
exact consequences of this reservoir to public health are at present unknown,
as no research has been done so far to reveal the dynamics of carriage and
association with disease of MRSA-CC398 in livestock farmers and their household
members.
Study objective
Primary objective: To determine the dynamics of MRSA carriage in persons
working on or living at pig and veal farms.
Secondary objectives: To determine the amount of disease associated with
carriage of MRSA-CC398. To determine the role of exposure to dust in the
environment on the occurence of disease.
Study design
In this study participants experience nasal and throat swabs, questionnaires
and environmental samples. Part of the nasal swabs, questionnaires and
environmental samples is taken by a trained representative of the study;
another part is taken by the participant himself. Throat swabs will only be
taken by trained representatives. In addition, blood samples will be taken on a
volunatary base, in order to determine genetical features of MRSA-carriage. In
some farms environmental samples will be validated by Anderson samplers.
Moreover, direct exposed persons are equipped with a portable pump, in order to
measure the dust and bacterial load during high risk tasks in the farm.
This study involves 3 sampling moments in the first week, and after this 1
sampling moment every 4 months ending 1 year after start of the study, adding
up to a total of 6 sampling moments. At the beginning as well as at the end of
the study, farms will be visited by a representative. The samples at moments in
between will be taken by the participants themselves. For an overview, see the
time schedule in the study protocol.
Study burden and risks
Participation in the study does not take much time (30-60 minutes per sampling
moment) and there are no invasive procedures. Altogether, 1 throat and 6 nasal
swab samples will be taken from all subjects, these will be tested for presence
of MRSA. Taking nose and throat swabs should not be considered to be much
discomfort to the subjects. Blood samples can be taken on a voluntary base, and
will not give much discomfort as well.
Furthermore, during the one year follow-up period questionnaires are taken at 6
moments. At the beginning and at the end of the study two extensive
questionnaires will be taken. There will be no physical or psychological
discomfort, no site visits and no physical examinations or other tests
associated with participation. Therefore, participation in the study will not
involve any substantial risk for the included subjects and the investigators
will not interfere with treatment.
Postbus 747
5000 AS Tilburg
NL
Postbus 747
5000 AS Tilburg
NL
Listed location countries
Age
Inclusion criteria
Individuals of any age are eligible and should be:
1 - Working with pigs or veal calves on a farm (primary exposed)
or
2 - Living on a pig or veal farm and not working with the animals (secondary exposed)
Exclusion criteria
- Treatment for colonization of MRSA in the last 3 months of any potential participant (farm will be excluded)
- Being colonized with other types of MRSA than CC398
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28121.008.09 |