Neutrophil granulocyte membrane-based biomarker discovery for discrimination between acute bacterial versus acute viral infection: a pilot study.

At present, it is often difficult to immediately diagnose the cause of an
infection as being bacterial or viral. Laboratory tests based on measurement of
C-Reactive Protein (CRP) and other serum proteins currently do not reach the
discriminatory power to accurately diagnose a bacterial infection in clinical
settings. Under many other circumstances these markers can be elevated while
there is no bacterial infection present. Therefore, it is necessary to
investigate novel biomarkers that have the capacity to detect and rule out
bacterial infection at the time the patient first presents with a suspected
infection at the emergency room or in the clinic. By doing so, the overuse of
antibiotics can be prevented. In addition, growing resistance of
microorganisms, adverse reactions to antibiotics and increasing health-care
costs can be averted. The overall aim of Levels Diagnostics, a startup company,
in cooperation with medical specialists from Leiden University Medical Center
(LUMC) and the Center for human drug research (CHDR) is to develop a rapid
diagnostic tool that can detect a bacterial infection by using host cell
(neutrophils and CD64+ cells) membrane bound proteins, specific for bacterial
infections. By offering a reliable diagnostic tool it will become possible to
enforce a policy restricting the use of antibiotic medication without risks for
the patients. This study is the first (pilot) clinical study.

Identification of host biomarkers, being membrane bound proteins, on both
neutrophils and CD64 expressing cells, that have discriminatory difference in
concentrations.

Non-interventional cohort study of 30 participants with acute bacterial
infections (N=10), acute viral infections (N=10) and healthy participants
(N=10).

At the time of clinical presentation, viral respiratory infections are hard to
distinguish from bacterial infections due to similar symptoms. As a result,
antibiotics are often prescribed to patients with a viral infection, fuelling
antibiotic resistance, increasing public health costs and unnecessary side
effects. The aim of the study is to identify novel membrane-bound biomarkers
that are specifically associated with bacterial infections and hence could
allow a reliable diagnosis. The outcome of this study could contribute to the
development of next generation biomarker tests, which in turn enable better
targeted antibiotic prescriptions, greatly benefiting patients.

The proposed biomarker search is performed on two EDTA blood tubes and 1
clothing tube drawn from healthy participants and participants suspected of
acute viral or bacterial respiratory infections. Participating in the study
will not add discomfort to the patient as blood samples will be taken as part
of routine procedure if possible, or taken by venipuncture with only the risk
of (minimal) skin bruising. There are no other risks associated with the
participation in this study.