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PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

J

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

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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