Sohag University Hospital
Sohag, Sohag Governorate, 82524, Egypt
NCT Number: NCT07696897
Ventilator-associated pneumonia (VAP) is a common and serious infection among mechanically ventilated ICU patients. Early diagnosis remains challenging because clinical and radiological findings may lack specificity. Procalcitonin (PCT) is a well-established biomarker of bacterial infection, while serum zinc has recently emerged as a potential marker of immune dysfunction and infection severity. This prospective observational cohort study will compare the diagnostic accuracy of serum procalcitonin and serum zinc for the diagnosis of ventilator-associated pneumonia in 84 adult ICU patients. Diagnostic performance will be assessed using ROC curve analysis, sensitivity, specificity, positive predictive value, and negative predictive value. Associations between biomarker levels, inflammatory markers, disease severity scores, and clinical outcomes will also be evaluated.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
Sohag, Sohag Governorate, 82524, Egypt
Ventilator-associated pneumonia (VAP) is a major healthcare-associated infection that develops in patients receiving invasive mechanical ventilation for at least 48 hours. It is associated with prolonged intensive care unit (ICU) stay, increased healthcare costs, greater need for organ support, and increased mortality. Despite advances in critical care, accurate and timely diagnosis of VAP remains challenging because clinical and radiological criteria alone may lack sufficient specificity.
Procalcitonin (PCT) is a well-established biomarker that rises in response to bacterial infections and has been used to support diagnosis, assess disease severity, and guide antibiotic therapy. Zinc is an essential trace element involved in immune regulation, inflammatory response, antioxidant defense, and maintenance of epithelial barrier integrity. Zinc deficiency is common among critically ill patients and has been associated with increased susceptibility to infection and poorer clinical outcomes.
This prospective observational cohort study will be conducted in the Intensive Care Unit of Sohag University Hospital. Eighty-four adult mechanically ventilated ICU patients with suspected ventilator-associated pneumonia will be enrolled. Clinical assessment, laboratory investigations, microbiological cultures, chest imaging, and severity scoring systems including SOFA and CURB-65 will be performed according to the study protocol.
Serum procalcitonin and serum zinc levels will be measured at the time of VAP suspicion and repeated after 72 hours. Blood cultures and respiratory samples will be obtained whenever possible before initiation of antibiotic therapy. Patients will be followed throughout their ICU stay to evaluate disease progression and clinical outcomes.
The primary objective of the study is to compare the diagnostic accuracy of serum procalcitonin and serum zinc for confirmed ventilator-associated pneumonia using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC) measurements.
Secondary objectives include comparison of sensitivity, specificity, positive predictive value, and negative predictive value of both biomarkers at predefined cutoff values; evaluation of the diagnostic performance of a combined biomarker model; assessment of correlations between biomarker levels and inflammatory markers such as C-reactive protein and white blood cell count; and evaluation of associations between biomarker levels, disease severity scores, duration of mechanical ventilation, length of ICU stay, and 28-day mortality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measurement of serum procalcitonin levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.
Measurement of serum zinc levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.
Time frame: At presentation (baseline)
Comparison of the diagnostic performance of serum procalcitonin and serum zinc using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC) for diagnosis of ventilator-associated pneumonia.
Time frame: At presentation (baseline)
Comparison of sensitivity and specificity of serum procalcitonin and serum zinc at pre-specified cutoff values for identification of bacterial pneumonia.
Time frame: At presentation (baseline)
Comparison of positive predictive value (PPV) and negative predictive value (NPV) of serum procalcitonin and serum zinc at pre-specified cutoff values.
Time frame: At presentation (baseline)
Evaluation of whether combining serum procalcitonin and serum zinc improves diagnostic performance compared with either biomarker alone.
Contact information is provided by the study sponsor or research team.
Sohag University
Other
Comparative Diagnostic Accuracy of Procalcitonin Versus Serum Zinc as Biomarkers for the Diagnosis of Ventilator Acquired Pneumonia in Adults Admitted to the ICU
Acronym: PROZINC-VAP
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