No registrations found.
ID
Source
Brief title
Health condition
immunocompromised traveller
imuungecompromiteerde reiziger
diabetic travelel
reiziger met diabetes mellitus
MTX
biological
Sponsors and support
Leids Universitair Medisch Centrum
Municipal Health Service The Hague
Intervention
Outcome measures
Primary outcome
The incidence, morbidity, mortality and association between variables will be calculated. These endpoints will be compared in several subpopulations.
In the immunocompromised patients, we will assess the association between subject-related variables (personal characteristics, including immigrant status, disease activity, cumulative use of immunosuppression, ...) on the one hand and travel-related disease variables (febrile illness, febrile respiratory illness, diarrhoea) on the other hand, after correcting for the independent travel-related variables (destination, duration, accommodation, purpose). Subjects reporting a travel-related disease will be compared to those reporting no travel-related disease.
Secondary outcome
1. Serum antibody levels at several time points before and after active immunisation against DTP, hepatitis A, hepatitis B, meningococci (A/C/Y/W-135) and Vi polysaccharide in relation to age, gender, medical condition, and type of immunosuppression;
2. Conversion rate in quantiferon testing and Interferon Gamma Release Assay (IGRA);
3. Distribution of regulatory T-cell subset markers in (high and low) responders to vaccinations;
4. Incidence of faecal carriage of potentially pathogenic micro-organisms after travel in the subgroup rheumatic travellers and travel companion (basic sample);
5. Incidence of carriage of MRSA, antibiotic-resistant Gram-negatives, and Clostridium in those hospitalized abroad;
6. Incidence of household transmission of the following indicator micro-organisms: methicillin-resistant Staphylococcus aureus (MRSA), Salmonella, extended spectrum betalactamase-producing or gentamycine-resistant Gram-negatives. Clostridium species in faeces, or penicillin-resistant pneumococci in throat.
Background summary
The number of individuals who are immunocompromised and travel abroad for professional or recreational purposes is increasing rapidly. This study will quantify the health risks, morbidity and consumption of professional medical care abroad and on return at home. In addition, the study will establish whether the standard vaccinations (DTP, hepatitis A, and Salmonella typhi polysaccharide Vi) will lead to protective serum antibody levels in this group of immunocompromised individuals.
Study objective
To quantify health risks in relation to preventive actions and consequences of illness related to
travel in immigrant and non-immigrant immunocompromised travellers treated
with MTX and/or anti-TNF-alpha monoclonals, imuran or rituximab.
Study design
N/A
Intervention
No intervention (Observational cohort study).
Divisie 4<br>
Infectieziekten<br>
Postbus 9600
H.J. Brockhoff
Leiden 2300 RC
The Netherlands
+31 (0)6 15035691
h.j.brockhoff@lumc.nl
Divisie 4<br>
Infectieziekten<br>
Postbus 9600
H.J. Brockhoff
Leiden 2300 RC
The Netherlands
+31 (0)6 15035691
h.j.brockhoff@lumc.nl
Inclusion criteria
Inclusion immunocompromised traveller:
1. The subject is treated OR have been treated for at least 3 months with one or more of the following medication: methotrexaat (Emthexate®, Ledertrexate®), Imuran® / Puri-Nethol®, leflunomide (Arava®) infliximab (Remicade®), etanercept (Enbrel®), adalimumab (Humira®), Abatacept (Orencia®), rituximab (Mabthera®), anakinra (Kineret®), tocilizumab (RoActemra®), Simponi® or Cimzia®;
2. Travelling to a (sub)tropical destination during therapy, OR returning from a (sub)tropical destination within a 3 months period after ending therapy;
3. A subject may be included without travel companion;
4. Is autochthon or non-western immigrant.
The group diabetic traveller:
1. Independent of type of diabetes mellitus (I or II);
2. Diabetic medication: Insulin and/or oral;
3. Independent of complications due to diabetes mellitus;
4. A diabetic subject may be included without travel companion;
5. Autochthon or non-western immigrant.
Exclusion criteria
The following persons cannot take part in this study:
1. Individuals less than 18 years;
2. Persons speaking another language than Dutch, Moroccan, Turkish or English;
3. Mentally incapacitated persons;
4. Western immigrant.
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 |
|---|---|
| NTR-new | NL3453 |
| NTR-old | NTR3604 |
| Other | METC Leiden University : p08.199 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |