Efficacy and safety of adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. standard dose in patients with septic shock. A multicenter, interventional, randomized, single-blinded, two arms, adaptive study design.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518096-57-00

Enrollment

356

Registered

2024-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Brief summary

All-cause mortality at day 28.

Detailed description

- All cause mortality at ICU discharge, hospital discharge at day90; - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay; - IFHs day28; - HFD day90; - VFDs day 28; - VasoFDs at day28; - AFDs day28; - ICU acquired weakness at 7, 28 and 90days or hospital discharge defined by MRC Scale; - Occurrence of protocol related adverse events at day28.

Interventions

DRUGPentaglobin 50 mg/ml soluzione per infusione

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
All-cause mortality at day 28.	—

Secondary

Measure	Time frame
- All cause mortality at ICU discharge, hospital discharge at day90; - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay; - IFHs day28; - HFD day90; - VFDs day 28; - VasoFDs at day28; - AFDs day28; - ICU acquired weakness at 7, 28 and 90days or hospital discharge defined by MRC Scale; - Occurrence of protocol related adverse events at day28.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026