Abstract
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. This trial investigated whether procalcitonin (PCT) ultrasensitive (PCTus)-guided antibiotic treatment of SAP can improve functional outcome after stroke. 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). 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). 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.
Highlights
Infections are among the most common acute complications after stroke and associated with poor outcome [1, 2]
Patients from 10 study centers were randomly assigned in a 1:1 ratio to standard stroke unit care plus PCT ultrasensitive (PCTus)-guided antibiotic treatment or to standard stroke unit care alone
Procalcitonin-based antibiotic therapy guidance was not associated with an increased proportion of acceptable outcome at 3 months, neither in the ITT nor in the PP or PPadherence analyses
Summary
Infections are among the most common acute complications after stroke and associated with poor outcome [1, 2]. Two large randomized controlled phase III clinical trials demonstrated that antibiotics commonly used to treat stroke-associated pneumonia (SAP) neither reduce the frequency of pneumonia nor improve the outcome after stroke when administered in a prophylactic manner [5,6,7]. Procalcitonin (PCT), an early marker of severe bacterial infections [10], has been useful in diagnosing SAP in previous observational clinical studies [11, 12]. We investigated whether PCT ultrasensitive (PCTus)-guided antibiotic treatment improves functional outcome after severe stroke by early identification and treatment of pneumonia. 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
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