PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

NCT03225079 | Terminated DMC

• 1 other identifier: ZKSJ0103_PERFORM
• Study Type: observational
• Target: 56
• Locations: 4 countries
• Sites: 12

Brief Summary

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

Conditions

Severe Bacterial Infection

Keywords

Pentaglobin® use; severe bacterial infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  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

  period between baseline and 24 hours after last application of Pentaglobin

• Duration of ICU stay (days)

  up to 6 months

• Duration of hospital stay (days)

  up to one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The recruitment will be primarily based on a severe bacterial infection of a patient and the following application of Pentaglobin®.

You may qualify if:

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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (12)

Hospital Sirio Libanes

São Paulo, Brazil

Location

Hospital Universitario Erasmo Meoz

Cúcuta, Colombia

Location

Clinic for Neurology

Jena, Thuringia, 07747, Germany

Location

Erzgebirgsklinikum Annaberg

Annaberg, Germany

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Universitätsklinikum Knappschaftskrankenhaus

Bochum, Germany

Location

Städtisches Klinikum Dresden

Dresden, Germany

Location

Universitätsklinikums Gießen & Marburg (UKGM)

Giessen, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Atatürk University Medical Faculty Trainer Hospital

Erzurum, 24240, Turkey (Türkiye)

Location

Eskişehir Osmangazi üniversitesi tıp fakültesi hastanesi

Eskişehir, 26480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Frank M Brunkhorst, Prof.Dr.

  Jena University Hospital, Center for Clinical Studies

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 21, 2017
• Study Start: November 8, 2017
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); CO (1); TU (2); DE (8)