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CD64 and Antibiotics in Human Sepsis (CD64SEPLDX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922998
Recruitment Status : Unknown
Verified November 2017 by Manfred Weiss, University of Ulm.
Recruitment status was:  Recruiting
First Posted : October 4, 2016
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Manfred Weiss, 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.

Condition or disease
Antibiotic Resistant Infection Critical Illness SIRS 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)?

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring CD64 on Neutrophils Regarding Effects of Antibiotics in Patients With SIRS Developing Sepsis
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis




Primary Outcome Measures :
  1. CD64 expression on neutrophils measured by LeukoDx [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Association of course of CD64 expression with effective antibiotic treatment [ Time Frame: 1 year ]

Other Outcome Measures:
  1. CD64 expression on neutrophils measured by FACS [ Time Frame: 1 year ]
  2. Association of CD64 expression with inflammatory markers [ Time Frame: 1 year ]
  3. Association of CD64 expression with cell surface markers on monocytes [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
blood, plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922998


Contacts
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Contact: Manfred Weiss, MD 49 (0)731-500-60226 manfred.weiss@uni-ulm.de
Contact: Marion E Schneider, PhD : 49 (0)731-500-60319 marion.schneider@uni-ulm.de

Locations
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Germany
Department of Anaesthesiology, University Hospital Ulm Recruiting
Ulm, Germany, 89075
Contact: Manfred E Weiss, MD    49 (0)731-500-60226    manfred.weiss@uni-ulm.de   
Contact: Elisabeth M Schneider, PhD    49 (0)731-500-60319    marion.schneider@uni-ulm.de   
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Manfred Weiss, MD Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075

Publications:
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Responsible Party: Manfred Weiss, Professor, MD, University of Ulm
ClinicalTrials.gov Identifier: NCT02922998    
Other Study ID Numbers: LeukoDx_CD64_AB_sepsis
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Manfred Weiss, University of Ulm:
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
Additional relevant MeSH terms:
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Sepsis
Toxemia
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents