AUTHOR=Ulm Lena , Hoffmann Sarah , Nabavi Darius , Hermans Marcella , Mackert Bruno-Marcel , Hamilton Frank , Schmehl Ingo , Jungehuelsing Gerhard-Jan , Montaner Joan , Bustamante Alejandro , Katan Mira , Hartmann Andreas , Ebmeyer Stefan , Dinter Christiane , Wiemer Jan C. , Hertel Sabine , Meisel Christian , Anker Stefan D. , Meisel Andreas 

TITLE=The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke

JOURNAL=Frontiers in Neurology

VOLUME=8

YEAR=2017

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2017.00153

DOI=10.3389/fneur.2017.00153

ISSN=1664-2295

ABSTRACT=<sec id="ST1"><title>Background</title><p>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.</p></sec><sec id="ST2"><title>Aims</title><p>This trial investigated whether procalcitonin (PCT) ultrasensitive (PCTus)-guided antibiotic treatment of SAP can improve functional outcome after stroke.</p></sec><sec id="ST3"><title>Methods</title><p>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 <uri xlink:href="http://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">http://ClinicalTrials.gov</uri> (Identifier NCT01264549).</p></sec><sec id="ST4"><title>Results</title><p>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, <italic>p</italic> = 0.47). Pneumonia rate and mortality were similar in both groups. Days with fever tended to be lower (<italic>p</italic> = 0.055), whereas total number of days treated with antibiotics were higher (<italic>p</italic> = 0.004) in PCT compared to control group. A <italic>post hoc</italic> 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 (<italic>p</italic> &lt; 0.0001).</p></sec><sec id="ST5"><title>Conclusion</title><p>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.</p></sec>