International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial
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
Study Type
OBSERVATIONAL
Enrollment
56
Hospital Sirio Libanes
São Paulo, Brazil
Hospital Universitario Erasmo Meoz
Cúcuta, Colombia
Clinic for Neurology
Jena, Thuringia, Germany
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
predicted mortality vs. observed hospital mortality
Time frame: up to 6 months
difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment
change in SOFA scores, baseline vs. posttreatment (24 hours after last application)
Time frame: baseline and 24 hours after last application of Pentaglobin
In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
Time frame: up to 6 months
Change in MOF score from the day before treatment start till 24 hours after last application of Pentaglobin
Change in MOF score from the day before treatment start till 24 hours after last application of Pentaglobin
Time frame: period between baseline and 24 hours 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
IL-6, IgM, IgA, IgG before treatment start till 24 hours after last application as far as available in the centers
Time frame: period between baseline and 24 hours after last application of Pentaglobin
Duration of ICU stay (days)
Duration of ICU stay (days)
Time frame: up to 6 months
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Erzgebirgsklinikum Annaberg
Annaberg, Germany
Universitätsklinikum Augsburg
Augsburg, Germany
Universitätsklinikum Knappschaftskrankenhaus
Bochum, Germany
Städtisches Klinikum Dresden
Dresden, Germany
Universitätsklinikums Gießen & Marburg (UKGM)
Giessen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
...and 2 more locations
Duration of hospital stay (days)
Duration of hospital stay (days)
Time frame: up to one year
Time from onset of severe bacterial infection to start of treatment
Time from onset of severe bacterial infection to start of treatment
Time frame: up to 14 days