Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Ventilator-Associated Pneumonia (REPLAY-VAP)

Ventilator-associated pneumonia (VAP) is a serious infection that occurs in patients who have been on mechanical ventilation for more than 48 hours in the intensive care unit (ICU). Early and accurate diagnosis is critical to reduce complications and improve outcomes. This prospective observational study aims to evaluate the diagnostic and prognostic value of reticulated platelet fraction (RP%) in patients diagnosed with VAP. Blood samples will be taken as part of routine care, and RP% levels will be analyzed using a standard hematology analyzer. The study will investigate whether RP% can help identify VAP earlier and predict outcomes such as mortality and response to antibiotics.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya City Hospital

Konya, Karatay, 42100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older
Receiving mechanical ventilation for more than 48 hours
Diagnosed with ventilator-associated pneumonia (VAP) according to clinical, radiologic, and laboratory criteria

Exclusion criteria

Diagnosis of pneumonia upon ICU admission
Pneumonia as the primary reason for initiation of mechanical ventilation
Mechanical ventilation duration less than 48 hours
Pregnant or breastfeeding patients
Presence of chronic inflammatory conditions, hematologic disorders, malignancy, autoimmune disease, or immunosuppressive/chemotherapy/radiotherapy treatment within the past 4 weeks

Treatment and study plan

Primary outcomes

Diagnostic accuracy of reticulated platelet fraction (RP%) in diagnosing ventilator-associated pneumonia (VAP)

Time frame: Within 48 hours of VAP diagnosis

Diagnostic performance of reticulated platelet fraction (RP%) measured as percentage (%) using the Sysmex XN-1000 hematology analyzer (from EDTA-anticoagulated whole blood). The outcome will be evaluated based on sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for VAP diagnosis, using established clinical and microbiological criteria as the reference standard.

Secondary outcomes

Correlation between baseline RP% and 28-day all-cause mortality

Time frame: 28 days from VAP diagnosis

Correlation between reticulated platelet fraction (RP%) measured by Sysmex XN-1000 hematology analyzer and 28-day all-cause mortality. Mortality will be recorded as a binary outcome (alive or dead at day 28), and correlation will be assessed using Spearman or point-biserial correlation coefficients, as appropriate.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Patients With Ventilator-Associated Pneumonia: A Prospective Observational Study

Acronym: REPLAY-VAP

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 10, 2025
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed