PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring (PERFORM)

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

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

Study Overview

• Status: Terminated
• Conditions: Severe Bacterial Infection

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

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Sirio Libanes
• Colombia
  • Cúcuta, Colombia
    • Hospital Universitario Erasmo Meoz
• Germany
  • Annaberg, Germany
    • Erzgebirgsklinikum ANNABERG
  • Augsburg, Germany
    • Universitatsklinikum Augsburg
  • Bochum, Germany
    • Universitätsklinikum Knappschaftskrankenhaus
  • Dresden, Germany
    • Städtisches Klinikum Dresden
  • Gießen, Germany
    • Universitätsklinikums Gießen & Marburg (UKGM)
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Tübingen, Germany
    • Universitätsklinikum Tübingen
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Clinic for Neurology
• Turkey
  • Erzurum, Turkey, 24240
    • Atatürk University Medical Faculty Trainer Hospital
  • Eskişehir, Turkey, 26480
    • Eskişehir Osmangazi üniversitesi tıp fakültesi hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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®.

Description

Inclusion Criteria:

Age ≥ 18 years

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Study Director: Frank M Brunkhorst, Prof.Dr., Jena University Hospital, Center for Clinical Studies

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): October 29, 2020

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Pentaglobin® use; severe bacterial infection
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections
• Other Study ID Numbers: ZKSJ0103_PERFORM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No