Background: Pneumonia is among the most common acute complications after
stroke and is associated with poor long-term outcome. Biomarkers may help
identifying stroke patients at high risk for developing stroke-associated
pneumonia (SAP) and to guide early treatment. Aims: This trial investigated
whether procalcitonin (PCT) ultrasensitive (PCTus)-guided antibiotic treatment
of SAP can improve functional outcome after stroke. Methods: In this
international, multicenter, randomized, controlled clinical trial with blinded
assessment of outcomes, patients with severe ischemic stroke in the middle
cerebral artery territory were randomly assigned within 40 h after symptom
onset to PCTus-based antibiotic therapy guidance in addition to stroke unit
care or standard stroke unit care alone. The primary endpoint was functional
outcome at 3 months, defined according to the modified Rankin Scale (mRS) and
dichotomized as acceptable (≤4) or unacceptable (≥5). Secondary endpoints
included usage of antibiotics, infection rates, days of fever, and mortality.
The trial was registered with http://ClinicalTrials.gov (Identifier
NCT01264549). Results: In the intention-to-treat-analysis based on 227
patients (112 in PCT and 115 in control group), 197 patients completed the
3-month follow-up. Adherence to PCT guidance was 65%. PCT-guided therapy did
not improve functional outcome as measured by mRS (odds ratio 0.79; 95%
confidence interval 0.45–1.35, p = 0.47). Pneumonia rate and mortality were
similar in both groups. Days with fever tended to be lower (p = 0.055),
whereas total number of days treated with antibiotics were higher (p = 0.004)
in PCT compared to control group. A post hoc analysis including all PCT values
in the intention-to-treat population demonstrated a significant increase on
the first day of infection in patients with pneumonia and sepsis compared to
patients with urinary tract infections or without infections (p < 0.0001).
Conclusion: PCTus-guided antibiotic therapy did not improve functional outcome
at 3 months after severe ischemic stroke. PCT is a promising biomarker for
early detection of pneumonia and sepsis in acute stroke patients
