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.
ID
Bron
Verkorte titel
Aandoening
immunocompromised traveller
imuungecompromiteerde reiziger
diabetic travelel
reiziger met diabetes mellitus
MTX
biological
Ondersteuning
Leids Universitair Medisch Centrum
Municipal Health Service The Hague
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence, morbidity, mortality and association between variables will be calculated. These endpoints will be compared in several subpopulations.
<br><br>
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
No intervention (Observational cohort study).
Publiek
Divisie 4<br>
Infectieziekten<br>
Postbus 9600
H.J. Brockhoff
Leiden 2300 RC
The Netherlands
+31 (0)6 15035691
h.j.brockhoff@lumc.nl
Wetenschappelijk
Divisie 4<br>
Infectieziekten<br>
Postbus 9600
H.J. Brockhoff
Leiden 2300 RC
The Netherlands
+31 (0)6 15035691
h.j.brockhoff@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3453 |
| NTR-old | NTR3604 |
| Ander register | METC Leiden University : p08.199 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |