PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

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

Detailed Description
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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

Official Title
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PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring, International Registry on the Use of Pentaglobin® in Patients With Severe Bacterial Infections

Conditions
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Severe Bacterial Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosis of severe bacterial infection Pentaglobin® use signed informed consent for data collection - Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APACHE II and SAPS II predicted mortality vs. observed hospital mortality and | predicted mortality vs. observed hospital mortality | 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) | baseline and 24 hours after last application of Pentaglobin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | period between baseline and 24 hours after last application of Pentaglobin | 
| Duration of ICU stay (days) | Duration of ICU stay (days) | up to 6 months | 
| Duration of hospital stay (days) | Duration of hospital stay (days) | 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 | up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pentaglobin® use, severe bacterial infection