Severe Bacterial InfectionPERFORMNCT03225079
PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring
An observational study of Severe Bacterial Infection, run by Jena University Hospital at 12 sites in 4 countries.
Trial summary
International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Bacterial Infection
- How many people
- 56 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 8 Nov 2017to 29 Oct 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The recruitment will be primarily based on a severe bacterial infection of a patient and the following application of Pentaglobin®.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of severe bacterial infection
- Pentaglobin® use
- signed informed consent for data collection -
Who cannot join
- -
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany8 sites
Erzgebirgsklinikum Annaberg
Annaberg
Universitätsklinikum Augsburg
Augsburg
Universitätsklinikum Knappschaftskrankenhaus
Bochum
Städtisches Klinikum Dresden
Dresden
Universitätsklinikums Gießen & Marburg (UKGM)
Giessen
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Clinic for Neurology
Jena, Thuringia, 07747
Universitätsklinikum Tübingen
Tübingen
Turkey (Türkiye)2 sites
Atatürk University Medical Faculty Trainer Hospital
Erzurum, 24240
Eskişehir Osmangazi üniversitesi tıp fakültesi hastanesi
Eskişehir, 26480
About this study
Official title: 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
Read the 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
- Conditions
- Severe Bacterial Infection
- Keywords
- Pentaglobin® use, severe bacterial infection
- Medical subject headings
- Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
predicted mortality vs. observed hospital mortality
Measured: 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)
Measured: baseline and 24 hours after last application of Pentaglobin
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: period between baseline and 24 hours after last application of Pentaglobin
Duration of ICU stay (days)
Duration of ICU stay (days)
Measured: up to 6 months
Duration of hospital stay (days)
Duration of hospital stay (days)
Measured: 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
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start8 Nov 2017
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Why it stopped: Insufficient recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Bacterial InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 56 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank M Brunkhorst, Prof.Dr., Study director, Jena University Hospital, Center for Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225079
- Sponsor's protocol ID
- ZKSJ0103_PERFORM
- Acronym
- PERFORM
- Status last verified
- Feb 2021
- First submitted
- 27 Jun 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring, International Registry on the Use of Pentaglobin® in Patients With Severe Bacterial Infections
- ClinicalTrials.gov ID
- NCT03225079
- Acronym / sponsor ID
- PERFORM / ZKSJ0103_PERFORM
- Conditions
- Severe Bacterial Infection
- Keywords
- Pentaglobin® use, severe bacterial infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment will be primarily based on a severe bacterial infection of a patient and the following application of Pentaglobin®.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of severe bacterial infection
- Pentaglobin® use
- signed informed consent for data collection -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
Time frame: up to 6 months
predicted mortality vs. observed hospital mortality
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)
6 secondary outcomes
In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP
Time frame: 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
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
Duration of ICU stay (days)
Time frame: up to 6 months
Duration of hospital stay (days)
Time frame: up to one year
Time from onset of severe bacterial infection to start of treatment
Time frame: up to 14 days
Results and safety
The study was stopped early (reason given: Insufficient recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank M Brunkhorst, Prof.Dr. study director
Jena University Hospital, Center for Clinical Studies
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Bacterial Infection, run by Jena University Hospital at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Turkey (Türkiye), Brazil, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APACHE II and SAPS II predicted mortality vs. observed hospital mortality and (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.