CD64 and Antibiotics in Human Sepsis | NCT02922998

Studies
CD64 and Antibiotics in Human Sepsis

NCT02922998

Sponsor

University of Ulm

Status

Completed

Last Update Posted

Dec 10, 2024Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Antibiotic Resistant Infection
Critical Illness
SIRS
Sepsis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Sep 26, 2016

First Submission Date that Met QC Criteria

Sep 30, 2016

First Posted Date

Oct 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2024

Last Update Posted Date

Dec 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

64Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill adult patients with SIRS at risk of sepsis with suspected infections in whom application of antibiotics is started

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manfred Weiss, MD	Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology, University Hospital Ulm		Ulm		89075	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11444911	Background	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.
12027409	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.

ID	Term
D016638	Critical Illness
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007239	Infections

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007249	Inflammation