CD64 and Antibiotics in Human Sepsis

Completed

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

• Registration Number: NCT02922998
• Lead Sponsor: University of Ulm

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)?

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Primary Completion: 2019-12-31
• Study Completion: 2021-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CD64 expression on neutrophils measured by LeukoDx	1 year

Secondary Outcome Measures

Name	Time	Method
Association of course of CD64 expression with effective antibiotic treatment	1 year

Trial Locations

Locations (1)

Department of Anaesthesiology, University Hospital Ulm; 🇩🇪 Ulm, Germany