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

February 18, 2021 updated by: Jena University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Hospital Sírio Libanês
  • Colombia
      • Cúcuta, Colombia
        • Hospital Universitario Erasmo Meoz
  • Germany
      • Annaberg, Germany
        • Erzgebirgsklinikum ANNABERG
      • Augsburg, Germany
        • Universitätsklinikum Augsburg
      • Bochum, Germany
        • Universitätsklinikum Knappschaftskrankenhaus
      • Dresden, Germany
        • Städtisches Klinikum Dresden
      • Gießen, Germany
        • Universitätsklinikums Gießen & Marburg (UKGM)
      • Hamburg, Germany
        • Universitatsklinikum Hamburg-Eppendorf
      • Tübingen, Germany
        • Universitatsklinikum Tubingen
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
Time Frame: up to 6 months
predicted mortality vs. observed hospital mortality
up to 6 months
difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment
Time Frame: baseline and 24 hours after last application of Pentaglobin
change in SOFA scores, baseline vs. posttreatment (24 hours after last application)
baseline and 24 hours after last application of Pentaglobin

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
Time Frame: up to 6 months
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
Time Frame: period between baseline and 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
Time Frame: period between baseline and 24 hours after last application of Pentaglobin
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)
Time Frame: up to 6 months
Duration of ICU stay (days)
up to 6 months
Duration of hospital stay (days)
Time Frame: up to one year
Duration of hospital stay (days)
up to one year
Time from onset of severe bacterial infection to start of treatment
Time Frame: up to 14 days
Time from onset of severe bacterial infection to start of treatment
up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jena University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Frank M Brunkhorst, Prof.Dr., Jena University Hospital, Center for Clinical Studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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