PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

Terminated

• Conditions: Severe Bacterial Infection

• Registration Number: NCT03225079
• Lead Sponsor: Jena University Hospital

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

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2017-11-08
• Primary Completion: 2020-10-29
• Study Completion: 2020-10-29
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Age ≥ 18 years

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and	up to 6 months	predicted mortality vs. observed hospital mortality
difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment	baseline and 24 hours after last application of Pentaglobin	change in SOFA scores, baseline vs. posttreatment (24 hours after last application)

Secondary Outcome Measures

Name	Time	Method
Duration of ICU stay (days)	up to 6 months	Duration of ICU stay (days)
In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP	up to 6 months	In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
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	Change in MOF score from the day before treatment start till 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	IL-6, IgM, IgA, IgG before treatment start till 24 hours after last application as far as available in the centers
Duration of hospital stay (days)	up to one year	Duration of hospital stay (days)
Time from onset of severe bacterial infection to start of treatment	up to 14 days	Time from onset of severe bacterial infection to start of treatment

Trial Locations

Locations (12)

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

Eskişehir Osmangazi üniversitesi tıp fakültesi hastanesi; 🇹🇷 Eskişehir, Turkey

Atatürk University Medical Faculty Trainer Hospital; 🇹🇷 Erzurum, Turkey