NCT03225079

PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Severe Bacterial Infection

Timeline

• Start date: 2017-11-08
• Primary completion: 2020-10-29
• Completion: 2020-10-29
• First posted: 2017-07-21
• Last updated: 2021-02-21

Locations

12 sites across 4 countries: Brazil, Colombia, Germany, Turkey (Türkiye)