Last updated on August 2019

PERFORM = Pentaglobin Registry For Outcome Report and Monitoring


Brief description of study

International registry on the use of Pentaglobin in patients with severe bacterial infections; multicentric, international registry, non-interventional trial

Detailed Study Description

Aim of the Pentaglobin registry of adult critically ill patients with severe infections is primarily to assess the effects of IVIgAM on the aforementioned outcome parameters and its side effects under real-life conditions based on a prospective, high-quality data documentation

  • Age 18 years
  • Diagnosis of severe bacterial infection
  • Pentaglobin use
  • signed informed consent for data collection

Exclusion criteria None

Primary endpoints

  • Comparison APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
  • Difference in SOFA scores, baseline vs. posttreatment (24 h after last application) assessment

Secondary endpoints

  • In-hospital mortality total and in subgroups according to baseline IgM serum levels (< 80 mg/dL vs. 80 mg/dL) and baseline CRP (< 70 mg/L vs. 70 mg/L)
  • Change in MOF score from the day before treatment start till 24 h after last application of Pentaglobin
  • Course of laboratory markers (concentration-difference): CRP, procalcitonin, IL-6, IgM, IgA, IgG before treatment start till 24 h after last application as far as available in the centers
  • Duration of ICU stay (days)
  • Duration of hospital stay (days)
  • Time from onset of severe bacterial infection to start of treatment

Clinical Study Identifier: NCT03225079

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Clinic for Neurology

Jena, Germany
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