CD64 and Antibiotics in Human Sepsis (CD64SEPLDX)

Monitoring CD64 on Neutrophils Regarding Effects of Antibiotics in Patients With SIRS Developing Sepsis

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Critical Illness; SIRS; Antibiotic Resistant Infection

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)?

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Manfred Weiss, MD; Phone Number: 49 (0)731-500-60226; Email: manfred.weiss@uni-ulm.de
• Study Contact Backup: Name: Marion E Schneider, PhD; Phone Number: : 49 (0)731-500-60319; Email: marion.schneider@uni-ulm.de

Study Locations

• Germany
  • Ulm, Germany, 89075
    • Recruiting
    • Department of Anaesthesiology, University Hospital Ulm
    • Contact: Manfred E Weiss, MD; Phone Number: 49 (0)731-500-60226; Email: manfred.weiss@uni-ulm.de
    • Contact: Elisabeth M Schneider, PhD; Phone Number: 49 (0)731-500-60319; Email: marion.schneider@uni-ulm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CD64 expression on neutrophils measured by LeukoDx	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Association of course of CD64 expression with effective antibiotic treatment	1 year

Other Outcome Measures

Outcome Measure	Time Frame
CD64 expression on neutrophils measured by FACS	1 year
Association of CD64 expression with inflammatory markers	1 year
Association of CD64 expression with cell surface markers on monocytes	1 year

Collaborators and Investigators

• Sponsor: University of Ulm
• Investigators: Principal Investigator: Manfred Weiss, MD, Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Infection; Antibiotics; Patients; Granulocyte Colony-Stimulating Factor; Biomarkers; Sepsis; Cytokines; procalcitonin; Human; C-reactive protein; Intensive Care Units; Systemic Inflammatory Response Syndrome; Interferon-gamma; Point-of-Care Systems; Interleukin-4; CD64 antigens; lipopolysaccharide-binding protein; Bedside Testing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Critical Illness
• Other Study ID Numbers: LeukoDx_CD64_AB_sepsis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO