Nosocomial Pseudomonas aeruginosa infections in mechanically ventilated ICU patients MedDRA version: 9.1 Level: PT Classification code 10061471 Term: Pseudomonas infection
Conditions
Interventions
Product Name: IC43
Product Code: IC43
Pharmaceutical Form: Suspension for injection
Other descriptive name: Aluminium hydroxide
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: e
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged between 18 and 80 years. Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0 At high risk for acquiring infection against P. aeruginosa (i.e. previous treatment against P. aeruginosa, diminished lung function, high probability for requiring ventilation for more than 48 hours) at visit 0. Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours. In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception, as specified in protocol Section 6.4 Written informed consent (e.g. by the patient or legal representative) or waiver according to the national regulations 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC43 vaccination at Visit 0 Low severity of illness defined by an acute physiology score < 8 at visit 0 Patients < 6 months post organ transplantation Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection Pregnancy (positive pregnancy test at study entry), lactation Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the immunogenicity of two different dosages of IC43 in mechanically ventilated ICU patients at day 14 after first vaccination;Secondary Objective: To investigate the immunogenicity of IC43 in mechanically ventilated ICU patients at day 7 and in biweekly intervals after day 14 until hospital discharge and day 90 To investigate the safety and tolerability of IC43 during a period of up to 90 days after the first vaccination To estimate the rate of invasive Pseudomonas aeruginosa (P. aeruginosa) infection in ICU patients receiving IC43 vaccination versus placebo during hospital stay To analyze and compare the incidence rates of colonization disease by P. aeruginosa in ICU patients receiving IC43 vaccination versus placebo To analyze the impact of IC43 vaccination on organ function, overall survival, time to onset of ventilator-associated pneumonia (VAP), length of stay in ICU and hospital, antibiotic use and overall infection rate To determine supportive immunological endpoints (OPA) ;Primary end point(s): Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo | — |
Countries
Austria, Belgium, Hungary, Spain
Outcome results
None listed