Download StaphTrav: a multicenter study of the importation of Staphylococcus

StaphTrav patient information engl. v1.1
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Replace by
Responsible investigator at site
Travel Clinic Address
Phone Number
Email
StaphTrav: a multicenter study of the importation of Staphylococcus aureus
through intercontinental travel
Information for study participants
Dear patient,
You have consulted our clinic today because of problems with your skin that are
timely associated with travelling. It is very likely, that this condition is an infection
caused by bacteria such as Staphylococcus aureus. We, a European team of
researchers in travel medicine and infectious diseases, believe that you have
acquired this infection while being abroad. Definite evidence for this hypothesis,
however, is missing. Such knowledge would be of great value as these bacteria are
increasingly causing diseases around the globe. Through your participation in this
study you could significantly contribute towards a better understanding on how these
bacteria spread and enter Europe which would help us to counsel other travellers on
this risk as well as on protective measures. In case you agree to participate either I or
one of my colleagues will take a swab from each wound and an additional one from
both openings of your nose. We will send these specimens to our research laboratory
at the University of Tübingen Medical School in Germany. Alongside these swabs,
you are asked to provide basic information on your last travel, the beginning and type
of symptoms as well as your age and gender without mentioning your name, date of
birth, address or any other identifying information. These swabs will be checked for
the growth of bacteria such as Staphylococcus aureus. No other investigations, in
particular none that concern parts of your body such as genetic testing will be part of
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Staphtrav patient information english v.1.1
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this research. There will also be no follow-up visits as part of this study. We will only
meet again in case this is required as part of regular care. I will receive a report of
our findings from Tübingen which I can share with you upon request. However,
participation in this study will not replace consultation of a microbiological laboratory
near our travel clinic. Depending on the severity of your skin infection, I will decide
whether this is necessary or not. The swabs taken for this study are harmless and
usually not painful. As for routine specimens we will use sterile cotton swabs. The
nasal swab will be taken from the lower part of both openings of your nose which can
lead to a short tearing of the eyes – a natural reaction of your body. Participation in
the study is voluntary. I assure that the quality of our care you will receive here at the
clinic is absolutely independent from your decision to participate in this study or not.
Do not hesitate to ask your doctor about further details of this study or contact the
coordinator, Dr. Philipp Zanger, Institut für Tropenmedizin, Wilhelmstraße 27, 72074
Tübingen, Germany, Tel.: +49 7071 29 82365, [email protected]
Dr. responsible at study site
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StaphTrav, Data storage and usage, v.1.1
_______________________________________________________________________
<<Name of site investigator>>
<<Name of clinic/institution>>
<<Address>>
<<Phone>>
<<Email>>
StaphTrav: a multicenter study of the importation of Staphylococcus
aureus through intercontinental travel
DECLARATION OF DATA PROTECTION AND USAGE
The data collected as part of this research study will be kept confidential and stored in a
pseudonymized form (e.g. a number code) – without mentioning the participant’s name, address
or date of birth. Only this pseudonym will be used to identify my specimens at the research lab. A
list that allows reassigning personal information to the pseudonym will be kept separately from the
study material in a locker and is only accessible to the doctors taking care of my treatment. All
data will be stored for 10 years. In case of scientific publication no personal information will be
publicly accessible. In case you decide to withdraw consent it is your decision to what extent the
data already collected at the local study centre may be used or has to be destroyed.
Consent
I hereby agree that the data collected as part of the research study „StaphTrav: a multicente
study of the importation of Staphylococcus aureus through intercontinental travel“ will be used as
set forth above. I know that I am allowed to view my data file kept at the local centre upon
request.
Place, Date
Signature
Name of participant in capitals
Staphtrav, consent form, v.1.1
_____________________________________________________________________________________
<<Name of site investigator>>
<<Name of clinic/institution>>
<<Address>>
<<Phone>>
<<Email>>
StaphTrav: a multicenter study of the importation of Staphylococcus
aureus through intercontinental travel
Informed patient consent
I, _________________________________(Name of patient), have fully read and understood the aims,
procedures, duration, risks and side effects involved in participation in this study set forth in the document
“Information for study participants”. I had ample time to ask further questions and feel fully informed about
all aspects the participation in this research might involve. I have been informed that participation in this
study is voluntary and that I am authorized to retract this consent at any time without giving reasons for this
decision and without any consequences for me and my further treatment as patient at this institution.
I have been informed about all issues of data storage, analysis and publication and have signed a separate
consent on the usage and protection of my data.
I agree in participating in this study. I herby agree that my microbiological specimens (swabs) alongside
with basic information about my disease and travel history will be analyzed for scientific purposes.
___________________, ___/___/__ __
Place, Date
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Name and signature of participant
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Place, Date
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Name and signature of responsible investigator