2 research outputs found
Lessons from everyday stroke care for clinical research and vice versa: comparison of a comprehensive and a research population of young stroke patients
Peer reviewe
The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke
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.peerReviewe