PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

Severe Bacterial Infection Clinical Trial

— PERFORM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03225079
• Other study ID #: ZKSJ0103_PERFORM
• Status: Terminated
• Start date: November 8, 2017
• Est. completion date: October 29, 2020

Study information

• Verified date: February 2021
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age = 18 years

• Diagnosis of severe bacterial infection

• Pentaglobin® use

• signed informed consent for data collection -

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Bacterial Infections
• Infection
• Severe Bacterial Infection

Locations

Country	Name	City	State
Brazil	Hospital Sirio Libanes	São Paulo
Colombia	Hospital Universitario Erasmo Meoz	Cúcuta
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	Clinic for Neurology	Jena	Thuringia
Germany	Universitätsklinikum Tübingen	Tübingen
Turkey	Atatürk University Medical Faculty Trainer Hospital	Erzurum
Turkey	Eskisehir Osmangazi üniversitesi tip fakültesi hastanesi	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Countries where clinical trial is conducted

Brazil,  Colombia,  Germany,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	APACHE II and SAPS II predicted mortality vs. observed hospital mortality and	predicted mortality vs. observed hospital mortality	up to 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	Duration of ICU stay (days)	Duration of ICU stay (days)	up to 6 months
Secondary	Duration of hospital stay (days)	Duration of hospital stay (days)	up to one year
Secondary	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