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Onderzoek naar infectieziekten (en de gevolgen) bij reizigers die reizen met afweeronderdrukkende medicijnen of met suikerziekte.


- candidate number13299
- NTR NumberNTR3604
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2012
- Secondary IDsp08.199 METC Leiden University
- Public TitleOnderzoek naar infectieziekten (en de gevolgen) bij reizigers die reizen met afweeronderdrukkende medicijnen of met suikerziekte.
- Scientific TitleImmunomodulatory treatment and travel-related health risks.
- ACRONYMOp reis
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedImmunocompromised traveller, Diabetic traveler, Methotrexate , Biological
- Inclusion criteriaInclusion 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 criteriaThe 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2009
- planned closingdate1-apr-2013
- Target number of participants2000
- InterventionsNo intervention (Observational cohort study).
- Primary outcomeThe 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 outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H.J. Brockhoff
- CONTACT for SCIENTIFIC QUERIESDr. MD. L.G. Visser
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Infectious Diseases
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Leiden University Medical Center (LUMC), Municipal Health Service The Hague
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD10-sep-2012 - 15-okt-2012


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