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Point of Care - Sepsis Study

Study acronym: POCT Sepsis
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date changed from estimate of Aug 15, 2026 to Aug 13, 2026 · Site details revised · Eligibility criteria expanded, about 4 words Show 3 more changesShow less
    • Start date changed from estimate of Aug 15, 2026 to Aug 13, 2026
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This pilot study will evaluate whether a rapid point-of-care blood test can help identify early signs of infection and sepsis in preterm infants. The study will include preterm infants born before 37 weeks of pregnancy who are admitted to the neonatal care unit and have a suspected infection. The researchers will measure several substances in the blood that can increase during infection, including interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP), and myxovirus resistance protein A (MxA). Results obtained with the point-of-care device will be compared with standard laboratory measurements. The researchers will also study whether measuring IL-6 and PCT during the first 12 hours of life may provide useful information about infection earlier than CRP testing and whether combined MxA and CRP measurements may help distinguish bacterial from viral infections. This is an observational study and will not change the infants' standard medical care or treatment. Results from the point-of-care device will not be used to make treatment decisions during the study. Blood samples will be collected as part of, or together with, routine blood sampling whenever possible. The study is expected to include approximately 40 preterm infants, with a maximum of 80 infants enrolled.
Trial Details
NCT Number NCT07774013
Lead Sponsor Medical University of Graz
Conditions Neonate, Sepsis, IL6, PCT, Point of Care
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov