This study aims to delineate the alterations in leukocyte function during ex-vivo host-pathogen interactions. These data will be correlated with several factors such as coexisting comorbidities (e.g. diabetes) and functional defects analyzed using…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will outline the differences in macrophage function, specifically
phagocytosis, bacterial killing, and cytokine response, in those at higher risk
of acquisition due to underlying comorbidities in melioidosis.
Secondary outcome
To delineate the underlying processes, such as gene expression and
immuno-metabolic profiles, to understand altered macrophage function.
Background summary
Melioidosis is a severe, emerging infectious disease caused by the bacterium
Burkholderia pseudomallei. It is widespread across the tropics, contributing to
high burden of community acquired sepsis (mortality ~40%) in some regions. The
majority of patients suffering from melioidosis have underlying risk factors,
most notably diabetes, renal failure, liver failure and thalassemia. Of
interest, HIV is not considered to be a risk factor for melioidosis. However,
despite prior work, there is still a lack of understanding on the cellular
immune responses in human melioidosis and patients with diabetes (12-fold
heightened risk) or other comorbidities.
Study objective
This study aims to delineate the alterations in leukocyte function during
ex-vivo host-pathogen interactions. These data will be correlated with several
factors such as coexisting comorbidities (e.g. diabetes) and functional defects
analyzed using ex-vivo stimulation models for cytokine production,
phagocytosis, and bacterial killing.
Study design
Observational study using ex vivo stimulation models of whole blood, PBMCs and
single cells, isolated from patients with underlying comorbidities recruited in
outpatient clinics of the Amsterdam UMC, location AMC.
Study burden and risks
The risks are negligible (associated with venepuncture) and the burden is
minimal. 50 ml of blood will be taken in a single visit. A very short
questionnaire will be filled in to reduce confounders. The study is group
related as these are the underlying risk factors for the disease in
epidemiological studies. As majority of patients will be recruited from
outpatient clinics, they will already have routine examinations and parameters
recorded.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
adult patient with one of the following comorbidities:
- Type II Diabetes (8% (182 mg/dL) < HBA1c >=8.0% (183 mg/dL);poorly
controlled),
- HIV-1 (200<= CD4 count >200),
- Renal failure (eGFR < 30 or on dialysis)
- Liver failure (Child-Pugh score A,B or C)
- Thalassaemia (with and without iron overload)
- COPD (2 < GOLD > 3/4).
Exclusion criteria
Patients < 18 years. Patients with immunosuppressive medication, a recent
infectious syndrome, or recent vaccination (within 30 days) will not be
included.
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 | NL80936.018.22 |