About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Age 18 to 70 years.
Adult patients admitted to the Intensive Care Unit.
Receiving invasive mechanical ventilation for at least 48 hours.
Clinical suspicion of ventilator-associated pneumonia (VAP).
Disqualifiers
- Age less than 18 years or greater than 70 years.
Known chronic liver disease.
End-stage renal disease requiring dialysis.
Immunocompromised patients (including HIV infection, chemotherapy, organ transplantation, or long-term immunosuppressive therapy).
Trial population
The study population will consist of adult patients aged 18 to 70 years admitted to the Intensive Care Unit of Sohag University Hospital who are receiving invasive mechanical ventilation for at least 48 hours and develop clinical suspicion of ventilator-associated pneumonia (VAP). Eligible participants will be enrolled consecutively and evaluated using clinical, radiological, microbiological, and laboratory criteria, including serum procalcitonin and serum zinc measurements.
Trial design
Cohort
Prospective
Treatments tested in this trial
Serum Procalcitonin Measurement
Diagnostic testMeasurement of serum procalcitonin levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.
Serum Zinc Measurement
Diagnostic testMeasurement of serum zinc levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy (AUC) of serum procalcitonin versus serum zinc for identification of bacterial pneumonia
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.
Secondary outcomes
Sensitivity and specificity of serum procalcitonin and serum zinc
Comparison of sensitivity and specificity of serum procalcitonin and serum zinc at pre-specified cutoff values for identification of bacterial pneumonia.
Positive predictive value and negative predictive value of serum procalcitonin and serum zinc
Comparison of positive predictive value (PPV) and negative predictive value (NPV) of serum procalcitonin and serum zinc at pre-specified cutoff values.
Diagnostic performance of combined serum procalcitonin and serum zinc model
Evaluation of whether combining serum procalcitonin and serum zinc improves diagnostic performance compared with either biomarker alone.
Sponsors and contacts
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