CD64 and Antibiotics in Human Sepsis

NCT02922998 | Completed

• 1 other identifier: LeukoDx_CD64_AB_sepsis
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• CD64 expression on neutrophils measured by LeukoDx

  1 year

Secondary Outcomes (1)

• Association of course of CD64 expression with effective antibiotic treatment

  1 year

Other Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• multiple admissions on ICU, (\>1 in last 2 weeks period)
• leukopenia \< 1 G/l
• and thrombocytopenia
• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital Ulm

Ulm, 89075, Germany

Location

Related Publications (5)

• 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.

  PMID: 11444911 BACKGROUND

• 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.

  PMID: 12027409 BACKGROUND

• 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.

  PMID: 7538851 BACKGROUND

• 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.

  PMID: 8833041 BACKGROUND

• 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.

  PMID: 11797018 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma

MeSH Terms

Conditions

Critical Illness; Sepsis; Systemic Inflammatory Response Syndrome; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Shock

Study Officials

• Manfred Weiss, MD

  Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2021
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)