Nosocomial Pseudomonas aeruginosa infections in mechanically ventilated ICU patients MedDRA version: 18.1 Level: PT Classification code 10061471 Term: Pseudomonas infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: IC43
Product Code: IC43
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IC43
Current Sponsor code: IC43
Concentration unit: µg/ml microgram(s)/millilitre
Concentration t
Sponsors
Valneva Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients admitted to an ICU with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0 Written informed consent (e.g., by the patient or his/her legally authorized representative) or waiver according to the national regulations No childbearing potential or negative pregnancy test 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 520 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
Exclusion criteria: SOFA < 4 on Day 0 Patients < 6 months post organ transplantation Expected plasmapheresis or immunoadsorption Readmission to ICU during the current total hospital stay on Day 0 Patients admitted to ICU within 48 hours after surgery or due to trauma at Day 0 Elective surgery until Day 28 after first vaccination
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints : 1) Day 14,56 and 90 all cause mortality in patients receiving IC43 or placebo 2) Day 28, 56 and 90 all cause mortality in patients surviving Day 14 and receiving IC43 or placebo 3) Day 14, 28, 56 and 90 all cause mortality in patients surviving Day 3 and receiving IC43 or placebo 4) Overall survival in all patients and in patients surviving Day 14 5) Day 28 all cause mortality in patients with documented medical history of a hepatobiliary disorder receiving IC43 or placebo 6) Overall survival in patients with documented medical history of a hepatobiliary disorder 7) Sepsis-related mortality at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo 8) Sepsis-related survival in patients receiving IC43 or placebo 9) In-ICU and in-hospital mortality in patients receiving IC43 or placebo until Day 14, 28, 56, 90, 180 10) Percentage of patients with invasive infection with P. aeruginosa, such as bacteremia (determined as positive blood culture) or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo within 28 and 56, 90 and 180 days after first vaccination 11) Percentage of patients with P. aeruginosa respiratory tract infection (pneumonia or tracheobronchitis) or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo within 28 and 56, 90 and 180 days after first vaccination 12) Organ function (Sequential Organ Failure Assessment [SOFA] scores) in patients receiving IC43 or placebo during ICU stay 13) Length of ICU stay in patients receiving IC43 or placebo Immunogenicity endpoints: 1) Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo Safety endpoints: 1) Rate of serious adverse events and adverse events during the vaccination period up to 180 days after the first vaccination 2) Systemic tolerability (Vital signs: blood pressure, pulse, body temperature) 3) Local tolera | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the superiority of IC43 with regard to overall mortality on Day 28 after first vaccination in mechanically ventilated ICU patients.;Secondary Objective: To investigate the effect of IC43 on overall mortality - up to 56 and 90 days after first vaccination - on Day 14, 28, 56 and Day 90 in subjects surviving Day 3 - on Day 28 , 56 and Day 90 in subjects surviving Day 14 To investigate the effect of IC43 on - overall survival - patients with history of a hepatobiliary disorder: overall mortality on Day 28 and overall survival - sepsis-related mortality - in-hospital mortality rates To analyze the impact of IC43 on sequential organ function assessments (SOFA) compared to placebo To compare incidence rates of - invasive P. aeruginosa (P.a.) infection in ICU patients receiving IC43 vs placebo - P. a. respiratory tract infection or colonization in ICU patients receiving IC43 vs placebo To investigate the - length of ICU stay in patients receiving IC43 vs placebo - immunogenicity of IC43 in mechanically ventilated ICU patients - safety and tolerability of IC43 during a period of up to 180 days after the first vaccination;Primary end point(s): Day 28 all cause mortality in patients receiving IC43 or placebo;Timepoint(s) of evaluation of this end point: Day 28 | — |
Countries
Austria, Belgium, Czech Republic, Germany, Hungary, Spain
Contacts
Public ContactHead of Clinical Operations
Valneva Austria GmbH
Outcome results
None listed