Procalcitonin Versus Serum Zinc for Diagnosis of Ventilator-Associated Pneumonia in ICU Patients (NCT07696897) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Procalcitonin Versus Serum Zinc for Diagnosis of Ventilator-Associated Pneumonia in ICU Patients
Egypt84 participantsStarted 2026-07-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- 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).
* New or progressive pulmonary infiltrate on chest imaging.
* At least two of the following:
* Fever \>38°C or hypothermia \<36°C.
* Leukocytosis (\>12,000/mm³) or leukopenia (\<4,000/mm³).
* Purulent tracheal secretions.
* Worsening oxygenation or increased ventilatory requirements.
* Written informed consent obtained from the patient or legally authorized representative.
Exclusion Criteria:
* \- 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).
* Current zinc supplementation or known disorders of zinc metabolism.
* Hematologic malignancies.
* Autoimmune diseases requiring immunosuppressive treatment.
* Active non-pulmonary bacterial infection requiring systemic antibiotic therapy.
* Chronic inflammatory diseases that may affect serum zinc levels.
* Pregnancy.
* Refusal or inability to provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy (AUC) of serum procalcitonin versus serum zinc for identification of bacterial pneumonia