Antibiotic Resistant InfectionCD64SEPLDXNCT02922998
CD64 and Antibiotics in Human Sepsis
An observational study of Antibiotic Resistant Infection and Critical Illness, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Resistant Infection, Critical Illness, SIRS
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients with SIRS at risk of sepsis with suspected infections in whom application of antibiotics is started
Who may be able to join
- age > 18 years
- critically ill adult patients
- sepsis
- SIRS
- initiation of antibiotic treatment
- patients < 48 hours after admission on ICU
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, University Hospital Ulm
Ulm, 89075
About this study
Official title: Monitoring CD64 on Neutrophils Regarding Effects of Antibiotics in Patients With SIRS Developing 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.
Read the 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
- 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
- Medical subject headings
- Critical Illness, Sepsis, Systemic Inflammatory Response Syndrome, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
CD64 expression on neutrophils measured by LeukoDx
Measured: 1 year
Secondary outcomes (1)
Association of course of CD64 expression with effective antibiotic treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion31 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Weiss, University of Ulm
- Investigators
- Manfred Weiss, MD, Principal investigator, Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922998
- Sponsor's protocol ID
- LeukoDx_CD64_AB_sepsis
- Acronym
- CD64SEPLDX
- Status last verified
- Dec 2024
- First submitted
- 26 Sep 2016
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 11444911Barth 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.
PubMed 12027409Weiss M, Gross-Weege W, Schneider M, Neidhardt H, Liebert S, Mirow N, Wernet P. Enhancement of neutrophil function by in vivo filgrastim treatment for prophylaxis of sepsis in surgical intensive care patients. J Crit Care. 1995 Mar;10(1):21-6. doi: 10.1016/0883-9441(95)90027-6.
PubMed 7538851Weiss M, Gross-Weege W, Harms B, Schneider EM. Filgrastim (RHG-CSF) related modulation of the inflammatory response in patients at risk of sepsis or with sepsis. Cytokine. 1996 Mar;8(3):260-5. doi: 10.1006/cyto.1996.0035.
PubMed 8833041Fischer G, Schneider EM, L Moldawer LL, Karcher C, Barth E, Suger-Wiedeck H, Georgieff M, Weiss M. CD64 surface expression on neutrophils is transiently upregulated in patients with septic shock. Intensive Care Med. 2001 Dec;27(12):1848-52. doi: 10.1007/s00134-001-1135-z. Epub 2001 Nov 8.
PubMed 11797018
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring CD64 on Neutrophils Regarding Effects of Antibiotics in Patients With SIRS Developing Sepsis
- ClinicalTrials.gov ID
- NCT02922998
- Acronym / sponsor ID
- CD64SEPLDX / LeukoDx_CD64_AB_sepsis
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients with SIRS at risk of sepsis with suspected infections in whom application of antibiotics is started
Key inclusion criteria (6 listed)
- age > 18 years
- critically ill adult patients
- sepsis
- SIRS
- initiation of antibiotic treatment
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CD64 expression on neutrophils measured by LeukoDx
Time frame: 1 year
1 secondary outcome
Association of course of CD64 expression with effective antibiotic treatment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 11444911Barth 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.
- Background: PubMed 12027409Barth 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.
- Background: PubMed 7538851Weiss M, Gross-Weege W, Schneider M, Neidhardt H, Liebert S, Mirow N, Wernet P. Enhancement of neutrophil function by in vivo filgrastim treatment for prophylaxis of sepsis in surgical intensive care patients. J Crit Care. 1995 Mar;10(1):21-6. doi: 10.1016/0883-9441(95)90027-6.
- Background: PubMed 8833041Weiss M, Gross-Weege W, Harms B, Schneider EM. Filgrastim (RHG-CSF) related modulation of the inflammatory response in patients at risk of sepsis or with sepsis. Cytokine. 1996 Mar;8(3):260-5. doi: 10.1006/cyto.1996.0035.
- Background: PubMed 11797018Fischer G, Schneider EM, L Moldawer LL, Karcher C, Barth E, Suger-Wiedeck H, Georgieff M, Weiss M. CD64 surface expression on neutrophils is transiently upregulated in patients with septic shock. Intensive Care Med. 2001 Dec;27(12):1848-52. doi: 10.1007/s00134-001-1135-z. Epub 2001 Nov 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Weiss, MD principal investigator
Department of Anaesthesiology, University Hospital Ulm; Ulm, Germany 89075
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistant Infection and Critical Illness, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD64 expression on neutrophils measured by LeukoDx (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922998, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.