A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aeruginosa - AERUMAB 11

• Conditions: ventilator associated pneumonia (VAP) caused by serotype O11 Pseudomonas aeruginosa; MedDRA version: 9.1Level: LLTClassification code 10065153Term: Ventilator associated pneumonia

• Registration Number: EUCTR2007-000442-12-GR
• Lead Sponsor: Kenta Biotech Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female = 18 years of age
2. Female patients sterilised, hysterectomised, post-menopausal, or negative pregnancy test at screening evaluation
3. Patient mechanically ventilated for at least 48 hours and clinical diagnosis (including a new or progressive infiltrate) of ventilator associated pneumonia (VAP), including recurrent VAP, with modified clinical pulmonary infection score (CPIS) higher than 3 points
4. Greater of equal to 6x105 CFU/mL of P. aeruginosa in quantification of mini-BAL tested with Roche-PCR-kit,and confirmed diagnosis of P. aeruginosa serotype O11 VAP tested in mini-BAL with Kenta-PCR-Kit
or
microbiologically confirmed diagnosis of P. aeruginosa serotype O11 VAP tested in miniBAL or BAL with conventional microbiology (equal or greater to 1x104 CFU/mL)
5. Patient is expected to survive longer than 72 hours
6. Written informed consent provided by relatives or the designated trusted person
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

1. Use of any investigational drug within 30 days preceding the first dose of AERUMAB 11, or planned use during the study and safety follow-up periods
2. Existence of any surgical or medical condition that might render the patient unduly susceptible to possible toxicity from the monoclonal antibody, including septic shock
(defined as hypotension, i.e. a systolic blood pressure < 90 mmHg, or a MAP < 60 mmHg, or a reduction of 40 mmHg in the systolic blood pressure from baseline,
despite adequate fluid resuscitation) with or without multiple organ dysfunction syndrome (MODS), and presence of clinically relevant disseminated intravascular
coagulation (overt DIC, as defined by a score of 5 or more using the scoring system proposed by the Scientific Subcommittee on Disseminated Intravascular Coagulation (DIC) of the ISTH) 3. Patients with a known hereditary complement deficiency
associated with systemic lupus erythematosus (SLE), paroxysmal nocturnal hemoglobinuria (PNH), hereditary angioedema (HAE), membranoproliferative
glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections
4. Confirmed Human Immunodeficiency Virus (HIV) infection
5. Transplant patients and/or sSimultaneous treatment with systemic immuno-suppressive drugs (prednisone or prednisolone allowed)
6. Patients with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh B or C) or acute hepatitis
7. Administration of poly- or mono-immunoglobulins within the three months preceding the first dose of study drug or planned administration during the study period
8. Neutropenic patients (absolute neutrophil count < 1000 cells per microlitre)

Study & Design

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