To establish efficacy of pre-travel vaccinations by determination of protective serum antibody titres against hepatitis A, DTP and polysaccharide Vi of Salmonella typhi. To quantify health risks related to preventive actions and consequences of…
ID
Source
Brief title
Condition
- Diabetic complications
- Autoimmune disorders
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To quantify travel-related infectious diseases
To measure the consequences of illness with regard to frequency and direct
costs of seeking medical care, the type of medical care, and the absence from
work.
To establish efficacy of pre-travel vaccinations by determination of protective
serum antibody titres against hepatitis A, DTP and polysaccharide Vi of
Salmonella typhi.
Secondary outcome
To develop evidence-based guidelines for the prevention of health problems in
the immunocompromised individuals treated with MTX and / or immunosuppressive
biologicals because of RA (or other medical conditions).
To quantify costs of travel advice and direct costs of seeking medical care and
number of day*s absence from work.
Background summary
International travel is undertaken by an ever-increasing number of people for
professional and recreational purposes, and more people travel greater
distances. Travellers are exposed to a variety of health risks in exotic
environments. Many of these risks are related to infectious diseases. In
particular, the individual immunocompromised by underlying medical condition or
treatment with immunomodulatory therapy (MTX, biologicals) is at risk for
acquiring an infection, and is more prone to suffer its adverse consequences.
Literature indicates that in the healthy population many of such health risks
can be minimised by suitable precautions taken before, during and after travel,
through health education, preventive vaccinations and prophylaxis. However, in
this respect there is a lack of information on individuals immunocompromised
due to MTX of biologicals. Moreover, the efficacy of preventive measures and
standard vaccinations in these individuals immunocompromised by underlying
medical condition or immunomodulatory drugs is largely unknown. Literature
provides no guidance on these issues, and *expert* opinions prevail.
Study objective
To establish efficacy of pre-travel vaccinations by determination of protective
serum antibody titres against hepatitis A, DTP and polysaccharide Vi of
Salmonella typhi.
To quantify health risks related to preventive actions and consequences of
illness related to travel in non-western immigrant and autochthonous
immunocompromised rheumatoid arthritis (RA) patients treated with MTX and/or
anti-TNF-alpha monoclonals or rituximab.
Study design
This is an observational cohort study.
Study burden and risks
Subject fill in 3 questionnairs, 3 diaries, and sent 2 faecal sample by mail,
travel time and blood samples. All these material are collected during a
periode of 12 months. Not all subject are sampeled an identical blood volume.
This depents on the exposition to health risks during travel.
Postbus 9600
2300 RC LEIDEN
NL
Postbus 9600
2300 RC LEIDEN
NL
Listed location countries
Age
Inclusion criteria
- a rheumatic condition; the subject is treated OR have been treated for at least 3 months with one or more of the following medication: methotrexaat (Emthexate®, Ledertrexate®), leflunomide (Arava®) infliximab (Remicade®), etanercept (Enbrel®), adalimumab (Humira®), Abatacept (Orencia®), rituximab (Mabthera®).)
- travelling to a (sub)tropical destination during therapy, OR returning from a (sub)tropical destination within a 3 months period after ending therapy.
Exclusion criteria
- individuals less than 18 years old;
- mentally incapacitated persons
Design
Recruitment
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 | NL25634.058.08 |