Clinical trial NCT03225079: PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring
Official title: PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring, International Registry on the Use of Pentaglobin® in Patients With Severe Bacterial Infections
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Bacterial Infection
Keywords: Pentaglobin® use
severe bacterial infection
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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®.

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

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years

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

Exclusion Criteria:

-

Primary outcomes:
measure: APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
timeFrame: up to 6 months
measure: difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment
timeFrame: baseline and 24 hours after last application of Pentaglobin
Secondary outcomes:
measure: In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
timeFrame: up to 6 months
measure: Change in MOF score from the day before treatment start till 24 hours after last application of Pentaglobin
timeFrame: period between baseline and 24 hours after last application of Pentaglobin
measure: 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
timeFrame: period between baseline and 24 hours after last application of Pentaglobin
measure: Duration of ICU stay (days)
timeFrame: up to 6 months
measure: Duration of hospital stay (days)
timeFrame: up to one year
measure: Time from onset of severe bacterial infection to start of treatment
timeFrame: up to 14 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sirio Libanes
city: Cúcuta
country: Colombia
facility: Hospital Universitario Erasmo Meoz
city: Jena
country: Germany
facility: Clinic for Neurology
state: Thuringia
city: Annaberg
country: Germany
facility: Erzgebirgsklinikum Annaberg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
city: Gießen
country: Germany
facility: Universitätsklinikums Gießen & Marburg (UKGM)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Erzurum
country: Turkey
facility: Atatürk University Medical Faculty Trainer Hospital
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi üniversitesi tıp fakültesi hastanesi
Study officials:
affiliation: Jena University Hospital, Center for Clinical Studies
name: Frank M Brunkhorst, Prof.Dr.
role: STUDY_DIRECTOR
References: