E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nosocomial Pseudomonas aeruginosa infections in mechanically ventilated ICU patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061471 |
E.1.2 | Term | Pseudomonas infection |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the immunogenicity of two different dosages and formulations of IC43 in mechanically ventilated ICU patients at day 14 after first vaccination |
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E.2.2 | Secondary objectives of the trial |
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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
Expected plasmapheresis or immunoadsorption during study period (at Visit 0)
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
PR3: open; PR1 and Placebo: double blind |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the date of the last visit performed by the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |