CD64 and Antibiotics in Human Sepsis

Sepsis Clinical Trial

— CD64SEPLDX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02922998
• Other study ID #: LeukoDx_CD64_AB_sepsis
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2016
• Last updated: November 7, 2017
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: November 2017
• Source: University of Ulm
• Contact: Manfred Weiss, MD
• Phone: 49 (0)731-500-60226
• Email: manfred.weiss[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Critical Illness
• Sepsis
• SIRS
• Toxemia

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Hospital Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. Epub 2001 Nov 8. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CD64 expression on neutrophils measured by FACS		1 year
Other	Association of CD64 expression with inflammatory markers		1 year
Other	Association of CD64 expression with cell surface markers on monocytes		1 year
Primary	CD64 expression on neutrophils measured by LeukoDx		1 year
Secondary	Association of course of CD64 expression with effective antibiotic treatment		1 year