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CD64 and Antibiotics in Human Sepsis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02922998
Acronym
CD64SEPLDX
Enrollment
64
Registered
2016-10-04
Start date
2016-09-30
Completion date
2021-06-30
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection, Critical Illness, Sepsis, SIRS

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

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)?

Interventions

None listed

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
CD64 expression on neutrophils measured by LeukoDx1 year

Secondary

MeasureTime frame
Association of course of CD64 expression with effective antibiotic treatment1 year

Other

MeasureTime frame
CD64 expression on neutrophils measured by FACS1 year
Association of CD64 expression with inflammatory markers1 year
Association of CD64 expression with cell surface markers on monocytes1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026