PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

NCT ID: NCT03225079

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2020-10-29

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years

• Diagnosis of severe bacterial infection
• Pentaglobin® use
• signed informed consent for data collection -

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank M Brunkhorst, Prof.Dr.

Role: STUDY_DIRECTOR

Jena University Hospital, Center for Clinical Studies

Locations

Hospital Sirio Libanes

São Paulo, , Brazil

Hospital Universitario Erasmo Meoz

Cúcuta, , Colombia

Clinic for Neurology

Jena, Thuringia, Germany

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

Atatürk University Medical Faculty Trainer Hospital

Erzurum, , Turkey (Türkiye)

Eskişehir Osmangazi üniversitesi tıp fakültesi hastanesi

Eskişehir, , Turkey (Türkiye)

Countries

Brazil; Colombia; Germany; Turkey (Türkiye)

Other Identifiers

ZKSJ0103_PERFORM

Identifier Type: -

Identifier Source: org_study_id