Procalcitonin Versus Serum Zinc for Diagnosis of Ventilator-Associated Pneumonia in ICU Patients

NCT07696897 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med--26-6-2MD
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilator Acquired Pneumonia

Keywords

Procaclcitonin pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  At presentation (baseline)

Secondary Outcomes (3)

• Sensitivity and specificity of serum procalcitonin and serum zinc

  At presentation (baseline)

• Positive predictive value and negative predictive value of serum procalcitonin and serum zinc

  At presentation (baseline)

• Diagnostic performance of combined serum procalcitonin and serum zinc model

  At presentation (baseline)

Study Arms (1)

Suspected VAP Patients

Adult mechanically ventilated ICU patients with suspected ventilator-associated pneumonia enrolled for diagnostic evaluation using serum procalcitonin and serum zinc measurements. Participants will subsequently be classified according to the final diagnosis of VAP based on clinical, radiological, and microbiological criteria.

Diagnostic Test: Serum Procalcitonin Measurement; Diagnostic Test: Serum Zinc Measurement

Interventions

Serum Procalcitonin Measurement DIAGNOSTIC_TEST

Measurement of serum procalcitonin levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.

Suspected VAP Patients

Serum Zinc Measurement DIAGNOSTIC_TEST

Measurement of serum zinc levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.

Suspected VAP Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82524, Egypt

Location

Related Publications (5)

• Schuetz P, Albrich W, Mueller B. Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future. BMC Med. 2011 Sep 22;9:107. doi: 10.1186/1741-7015-9-107.

  PMID: 21936959 BACKGROUND

• Meisner M. Update on procalcitonin measurements. Ann Lab Med. 2014 Jul;34(4):263-73. doi: 10.3343/alm.2014.34.4.263. Epub 2014 Jun 19.

  PMID: 24982830 BACKGROUND

• Prasad AS. Zinc in human health: effect of zinc on immune cells. Mol Med. 2008 May-Jun;14(5-6):353-7. doi: 10.2119/2008-00033.Prasad.

  PMID: 18385818 BACKGROUND

• Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med. 2020 May;46(5):888-906. doi: 10.1007/s00134-020-05980-0. Epub 2020 Mar 10.

  PMID: 32157357 BACKGROUND

• Becker KL, Snider R, Nylen ES. Procalcitonin assay in systemic inflammation, infection, and sepsis: clinical utility and limitations. Crit Care Med. 2008 Mar;36(3):941-52. doi: 10.1097/CCM.0B013E318165BABB.

  PMID: 18431284 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mahmoud Adel Mahmoud, Assisstant lecturer

CONTACT

+201110437575; adel.islam2@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mahmoud Adel Mahmoud

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)