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Completed

NCT Number: NCT02922998

CD64 and Antibiotics in Human Sepsis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology, University Hospital Ulm

Ulm, 89075, Germany

About this study

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)?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CD64 expression on neutrophils measured by LeukoDx

    Time frame: 1 year

Secondary outcomes

  1. Association of course of CD64 expression with effective antibiotic treatment

    Time frame: 1 year

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Acronym: CD64SEPLDX

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Oct 4, 2016
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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