PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

Jena University Hospital

Status: Terminated

Conditions: Severe Bacterial Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03225079

ZKSJ0103_PERFORM

Details and patient eligibility

About

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

Full 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

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years

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

Exclusion criteria