A PHASE 2 PILOT STUDY ASSESSING IMMUNOGENICITY AND SAFETY OF IC43 IN INTENSIVE CARE PATIENTS. - IC43-201

• Conditions: osocomial Pseudomonas aeruginosa infections in mechanically ventilated ICU patients; MedDRA version: 9.1Level: PTClassification code 10061471Term: Pseudomonas infection

• Registration Number: EUCTR2008-005037-30-BE
• Lead Sponsor: Intercell AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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

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 sutdy period (at Visit 0)

Study & Design

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