Ventilator Acquired PneumoniaPROZINC-VAPNCT07696897
Procalcitonin Versus Serum Zinc for Diagnosis of Ventilator-Associated Pneumonia in ICU Patients
An observational study of Ventilator Acquired Pneumonia, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator Acquired Pneumonia
- What is being tested?
- Serum Procalcitonin Measurement and Serum Zinc Measurement
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- - 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:
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- 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.
Who cannot join
- - 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag, Sohag Governorate, 82524
Alhadad Ali Mousa, Professor, +201019816967, Alhadad21@gmail.com
About this study
Official title: Comparative Diagnostic Accuracy of Procalcitonin Versus Serum Zinc as Biomarkers for the Diagnosis of Ventilator Acquired Pneumonia in Adults Admitted to the ICU
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.
Read the detailed description
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.
- Conditions
- Ventilator Acquired Pneumonia
- Being tested
- Serum Procalcitonin Measurement, Serum Zinc Measurement
- Keywords
- Procaclcitonin pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Procalcitonin MeasurementDiagnostic test
Measurement of serum procalcitonin levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.
Serum Zinc MeasurementDiagnostic test
Measurement of serum zinc levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serum Procalcitonin Measurement; Diagnostic Test: Serum Zinc Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At presentation (baseline)
Secondary outcomes (3)
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.
Measured: At presentation (baseline)
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.
Measured: At presentation (baseline)
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.
Measured: At presentation (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilator Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Adel Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696897
- Sponsor's protocol ID
- Soh-Med--26-6-2MD
- Acronym
- PROZINC-VAP
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available. Data will be used solely for the purposes of this research project and related scientific publications. Participant confidentiality and privacy will be protected in accordance with institutional ethical guidelines and applicable regulations.
Publications
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.
PubMed 21936959Meisner 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.
PubMed 24982830Prasad 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.
PubMed 18385818Papazian 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.
PubMed 32157357Becker 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.
PubMed 18431284
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Diagnostic Accuracy of Procalcitonin Versus Serum Zinc as Biomarkers for the Diagnosis of Ventilator Acquired Pneumonia in Adults Admitted to the ICU
- ClinicalTrials.gov ID
- NCT07696897
- Acronym / sponsor ID
- PROZINC-VAP / Soh-Med--26-6-2MD
- Conditions
- Ventilator Acquired Pneumonia
- Keywords
- Procaclcitonin pneumonia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected VAP Patients | – | Diagnostic Test: Serum Procalcitonin Measurement, Diagnostic Test: Serum Zinc MeasurementAdult 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- - 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.
Key exclusion criteria (11 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Procalcitonin MeasurementMeasurement of serum procalcitonin levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia. | Diagnostic test | Suspected VAP Patients |
| Serum Zinc MeasurementMeasurement of serum zinc levels for evaluation of diagnostic accuracy in ventilator-associated pneumonia. | Diagnostic test | Suspected VAP Patients |
Primary outcome
Diagnostic accuracy (AUC) of serum procalcitonin versus serum zinc for identification of bacterial 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.
3 secondary outcomes
Sensitivity and specificity of serum procalcitonin and serum zinc
Time frame: At presentation (baseline)
Positive predictive value and negative predictive value of serum procalcitonin and serum zinc
Time frame: At presentation (baseline)
Diagnostic performance of combined serum procalcitonin and serum zinc model
Time frame: At presentation (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 21936959Schuetz 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.
- Background: PubMed 24982830Meisner 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.
- Background: PubMed 18385818Prasad 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.
- Background: PubMed 32157357Papazian 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.
- Background: PubMed 18431284Becker 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.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available. Data will be used solely for the purposes of this research project and related scientific publications. Participant confidentiality and privacy will be protected in accordance with institutional ethical guidelines and applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Acquired Pneumonia, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Adel Mahmoud, Assisstant lecturer (+201110437575, adel.islam2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (AUC) of serum procalcitonin versus serum zinc for identification of bacterial pneumonia (time frame: At presentation (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07696897, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.