An observational study in Pseudomonas Infections, Pseudomonas Septicemia and Pseudomonas; Pneumonia, sponsored by University of Ulm. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by University of Ulm · Observational
Among 15 studies in Pseudomonas Infections with a site in Germany — 1 open to participants now, 1 under way, none of them phase 3. Pseudomonas Infections · Germany.
Among the 15 studies in Pseudomonas Infections with a site in Germany, this one is the only one that started in 2014, is the only observational one, and was the 15th registered.
136 studies on the registry are indexed under Pseudomonas Infections; 27 are open to participants now.
Browse Pseudomonas Infections studies →1 of the 15 studies in Pseudomonas Infections with a site in Germany is open now.
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 20 Pseudomonas Infections studies recruiting now, 11 (55%) set no upper age limit and 2 (10%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 5 · Phase 4 2
First in 2006; this study’s year is marked. 1 started in 2014.
This study's planned enrollment of 100 is close to the median of 100 across 38 observational studies indexed under Pseudomonas Infections.
Median enrollment 61 across the 14 interventional studies, 100 across the 1 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
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10 of 15 have an industry lead sponsor. The 10 most frequent:
University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
University of Ulm has 1 study filed under Pseudomonas Infections — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Pseudomonas Infections with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The present study focuses on patients with Pseudomonas aeruginosa (PSA) sepsis. The aim of the present study is to find out whether the M1 (pro-inflammatory) or M2 (anti-inflammatory) phenotype predominates in blood monocytes in critically ill patients with PSA-sepsis, and whether the severity of sepsis and outcome is associated with distinct monocyte phenotype and function.
During bacterial related sepsis, one of the key playing cells are macrophages, monocytes and T-lymphocytes (Hotchkiss et al., 2003). Macrophages and monocytes are supposed to be essential for the septic reaction to Gram-negative bacteria (Hotchkiss et al. 2003). Generally, there are two dominant types of macrophages: the pro-inflammatory M1 macrophage and the anti-inflammatory M2 macrophage (Mantovani et al., 2006). Similar to this macrophage characteristics, monocytes can also be categorized into pro-or anti-inflammatory. These macrophage/monocyte phenotypes can be differentiated in vitro from freshly isolated human blood monocytes using either GM-CSF giving raise to M1 macrophage/monocyte or M-CSF resulting in M2 macrophage/monocyte (Mantovani et al., 2006; Neu et al., 2013). Brunialti et al. (2012) have already demonstrated that the population of antiinflammatory M2 monocytes in septic patients is bigger than the pro-inflammatory M1 population. However, the authors did not further analyze the underlying mechanisms of M2 polarization nor did they identify the sepsis-causing pathogens.
In the present study, monocytes and macrophages of patients with Pseudomonas aeruginosa (PSA) sepsis are characterized by their surface marker expression profile via flow cytometry and cytokine pattern by ELISA in vivo and after ex-vivo LPS stimulation. In addition, an ex-vivo model system for PSA induced sepsis is validated. Blood of critically ill patients in the ICU infected with PSA is sampled to isolate peripheral blood mononuclear cells (PBMCs). Blood monocytes are analyzed for surface marker expression to determine the relative proportions of M1 and M2 monocytes in these patients and in healthy controls by flow cytometry
Critically ill patients with sepsis with microbiologically proven infection with Pseudomonas aeruginosa
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Monocyte surface marker expression in critically ill patients with Pseudomonas aeruginosa sepsis
Monocyte type 1, type 2 surface marker expression
Time frame: two years
Cytokine concentrations in serum and production after ex-vivo stimulation of isolated monocytes of critically ill patients with Pseudomonas aeruginosa sepsis with LPS
IL-8 and IFN-gamma
Time frame: four years
Plan to share: No
The record gives a start of Aug 2014, a primary completion of Nov 2025 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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