Clinical study evaluating the efficacy and safety of IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. IgM-enriched immunoglobulin standard dose in patients with septic shock

Phase 1

• Conditions: Septic shock; MedDRA version: 23.1Level: LLTClassification code 10040580Term: Shock septicSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2018-001613-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-18
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

- Age > 18 years;
- Septic shock occurrence < 24 hours; septic shock is identified according to Sepsis-3 definition by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia in patients with sepsis. Sepsis is defined as a life threatening organ dysfunction identified as an acute change in total SOFA score greater or equal to 2 points consequent to the infection;
- IgM-titers < 60mg/dl (or < 20% of the lower threshold value of local laboratory) within 24 hours from shock occurrence.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 143
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 213

Exclusion Criteria

- Shock of uncertain diagnosis;
-Hypersensitivity to IgM Preparation in use or its excipients;
- Patients receiving intravenous immunoglobulins (e.g. IgG or IgM enriched preparations) for > 6 hours before enrolment;
- Selective absolute IgA deficiency with antibodies to IgA;
- Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available;
- Clinical decision to withhold life-sustaining treatment or too sick to benefit”;
- Neutrophil count <1.000/mm3;
- Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);
- Patients with a known, chronic kidney dysfunction needing dialysis (creatinine greater or equal to 3.4 mg/dl or creatinine clearance lower or equal to 30 ml/min/1.73m2);
- Body Mass Index (BMI) >40;
- Participation in other clinical trials on adjunctive therapies for sepsis (during past 3 months);
- Lack or withdrawal of informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified