Clinical trial NCT02922998: CD64 and Antibiotics in Human Sepsis
Official title: Monitoring CD64 on Neutrophils Regarding Effects of Antibiotics in Patients With SIRS Developing Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Resistant Infection
Critical Illness
SIRS
Sepsis
Keywords: CD64 antigens
Biomarkers
Granulocyte Colony-Stimulating Factor
Interleukin-4
Interferon-gamma
C-reactive protein
lipopolysaccharide-binding protein
procalcitonin
Cytokines
Patients
Human
Systemic Inflammatory Response Syndrome
Sepsis
Infection
Antibiotics
Intensive Care Units
Point-of-Care Systems
Bedside Testing
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adult patients with SIRS at risk of sepsis with suspected infections in whom application of antibiotics is started

Brief summary: The purpose of the study is to find out whether CD64 expression on neutrophils measured by a new bedside test (LeukoDx) within 30 minutes is associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis.

Detailed description: In the present study, in critically ill patients with suspected infection undergoing application of antibiotics, CD64 and inflammatory plasma markers will be determined on days 1 to 4.

CD64 expression on the surface of neutrophils will be determined by fluorescence activated cell sorter (FACS) and with a new bedside test (LeukoDx).

The purpose of the study is to clarify:

1. Is CD64 expression on neutrophils associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis?
2. Is CD64 expression associated with distinct plasma parameters of inflammation?
3. Do the results of the gold standard CD64 determination by FACS correlate with those of a new bedside test (LeukoDx)?

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* critically ill adult patients
* sepsis
* SIRS
* initiation of antibiotic treatment
* patients \< 48 hours after admission on ICU

Exclusion Criteria:

* multiple admissions on ICU, (\>1 in last 2 weeks period)
* leukopenia \< 1 G/l
* and thrombocytopenia
* rhG-CSF or IFN-gamma therapy up to 1 week before inclusion
* participation in another study receiving drugs or biological within the preceeding 30 days
* recent longterm corticosteroid treatment
* HIV
* patients after organ transplantation treated with immunomodulating drugs
* pregnant patients or after delivery
* life expectancy \< 24 hours
* polytraumatized patients with reanimation on scene, or infest prognosis
* patients under high dose corticosteroids or chemotherapy

Primary outcomes:
measure: CD64 expression on neutrophils measured by LeukoDx
timeFrame: 1 year
Secondary outcomes:
measure: Association of course of CD64 expression with effective antibiotic treatment
timeFrame: 1 year
Other outcomes:
measure: CD64 expression on neutrophils measured by FACS
timeFrame: 1 year
measure: Association of CD64 expression with inflammatory markers
timeFrame: 1 year
measure: Association of CD64 expression with cell surface markers on monocytes
timeFrame: 1 year
Locations:
city: Ulm
country: Germany
facility: Department of Anaesthesiology, University Hospital Ulm
Study officials:
affiliation: Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075
name: Manfred Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barth E, Fischer G, Schneider EM, Wollmeyer J, Georgieff M, Weiss M. Differences in the expression of CD64 and mCD14 on polymorphonuclear cells and on monocytes in patients with septic shock. Cytokine. 2001 Jun 7;14(5):299-302. doi: 10.1006/cyto.2001.0880.
citation: Barth E, Fischer G, Schneider EM, Moldawer LL, Georgieff M, Weiss M. Peaks of endogenous G-CSF serum concentrations are followed by an increase in respiratory burst activity of granulocytes in patients with septic shock. Cytokine. 2002 Mar 7;17(5):275-84. doi: 10.1006/cyto.2002.1010.
citation: Weiss M, Gross-Weege W, Schneider M, Neidhardt H, Liebert S, Mirow N, Wernet P. Enhancement of neutrophil function by in vivo filgrastim treatment for prophylaxis of sepsis in surgical intensive care patients. J Crit Care. 1995 Mar;10(1):21-6. doi: 10.1016/0883-9441(95)90027-6.
citation: Weiss M, Gross-Weege W, Harms B, Schneider EM. Filgrastim (RHG-CSF) related modulation of the inflammatory response in patients at risk of sepsis or with sepsis. Cytokine. 1996 Mar;8(3):260-5. doi: 10.1006/cyto.1996.0035.
citation: Fischer G, Schneider EM, L Moldawer LL, Karcher C, Barth E, Suger-Wiedeck H, Georgieff M, Weiss M. CD64 surface expression on neutrophils is transiently upregulated in patients with septic shock. Intensive Care Med. 2001 Dec;27(12):1848-52. doi: 10.1007/s00134-001-1135-z. Epub 2001 Nov 8.