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

Immunomodulatory treatment and travel-related health risks.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24814
Enrollment
2000
Registered
2012-09-10
Start date
2009-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immunocompromised traveller imuungecompromiteerde reiziger diabetic travelel reiziger met diabetes mellitus MTX biological

Interventions

No intervention (Observational cohort study).

Sponsors

None listed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactH.J. Brockhoff

Leids Universitair Medisch Centrum Divisie 4 Infectieziekten Postbus 9600

h.j.brockhoff@lumc.nl+31 (0)6 15035691

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)