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

• Conditions: hospital acquired pneumonia caused by serotype O11 P.aeruginosa

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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.Patients under intensive care management with hospital-acquired pneumonia
4.In intubated patients confirmed microbiological diagnosis of P. aeruginosa serotype O11 HAP by lower respiratory tract specimen (BAL or miniBAL) with equal or greater to 1x104 CFU/mL, or between 1x10^3 and 1x10^4 CFU/ml if the patient is under antibiotic treatment, and presence of a new or progressing pulmonary infiltrate, plus one of the three following criteria: a) fever greater than 38oC, b) WBC greater than 10,000/mm3, or c) purulent sputum

in non-intubated patients confirmed microbiological diagnosis of P. aeruginosa serotype O11 HAP by endotracheal aspirate (ETA) with equal or greater to 1x106 CFU/mL, and modified clinical pulmonary infection score (CPIS) higher than 6 points

Note: Serotyping may either be done with conventional microbiology/serology or PCR

5.Patient is expected to survive longer than 72 hours
6.Written informed consent provided by the patient or by the 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 with unstable hemodynamics, as defined by a systolic blood pressure below 90 mmHg, despite vasopressor administration of epinephrine / norepinephrine at a dosage of greater than 0.1 µg/kg/min or dopamine at a dosage of greater 15 µg/kg/min), 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 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 simultaneous treatment with systemic immuno-suppressive drugs. However, prednisone or prednisolone are 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