Working… Menu

Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851435
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : July 30, 2009
Information provided by:
Kenta Biotech Ltd

Brief Summary:
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of KBPA-101 every third day in addition of standard of care antibiotic treatment.

Condition or disease Intervention/treatment Phase
Pneumonia Ventilator Associated Pneumonia Biological: KBPA-101 Phase 1 Phase 2

Detailed Description:
Hospital acquired pneumonia (HAP) is a pneumonia occurring 48 hours or more after hospital admission. HAP occurs in patients on conventional hospital wards and in intensive care units (ICU), some of them associated to mechanical ventilation, known as Ventilator Associated Pneumonia (VAP). VAP is the most common infection on intensive care units representing 82% of HAP cases. Pseudomonas aeruginosa is one of the most frequent pathogens involved in ICU-HAP and despite of adequate treatment its crude mortality remains as high as 70% of the cases.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-comparative Open Pilot Trial to Assess the Safety and Pharmacokinetics of up to Three Single Doses of AERUMAB 11 (KBPA-101) in Patients With Hospital Acquired Pneumonia Caused by Serotype O11 P. Aeruginosa
Study Start Date : February 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: KBPA-101, a monoclonal antibody
1.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day
Biological: KBPA-101
1.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day

Primary Outcome Measures :
  1. Assessment of physical examination, laboratory parameters, vital signs, ECG and any adverse at repeated times since the screening phase till the end of the study. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. To confirm the therapeutic plasma concentration of KBPA-101 [ Time Frame: 30 days ]
  2. To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Patients under intensive care management with hospital acquired pneumonia
  • Microbiological diagnosis of P. aeruginosa serotype O11 HAP by lower respiratory tract specimen (BAL or miniBAL) 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) and modified clinical pulmonary infection score (CPIS) higher than 6 points
  • Patient is expected to survive longer than 72 hours
  • Written informed consent provided by the patient or by the relatives or the designated trusted person

Exclusion Criteria:

  • Use of any investigational drug within 30 days preceding the first dose of KBPA-101, or planned use during the study and safety follow-up periods
  • 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,
  • Patients with a known complement deficiency associated with systemic lupus erythematosus, paroxysmal nocturnal hemoglobinuria, hereditary angioedema, membranoproliferative glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections
  • Confirmed Human Immunodeficiency Virus (HIV) infection
  • Transplant patients and/or simultaneous treatment with systemic immuno-suppressive drugs.
  • Patients with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh B or C) or acute hepatitis
  • Administration of poly- or mono-immunoglobulins within the three months preceding the first dose of study drug or planned administration during the study period
  • Neutropenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851435

Layout table for location information
Several sites in Switzerland, France, Belgium and Greece
Basel, Switzerland
Sponsors and Collaborators
Kenta Biotech Ltd
Layout table for investigator information
Study Director: Violetta Georgescu Kenta Biotech Ltd
Layout table for additonal information
Responsible Party: Violetta Georgescu, Kenta Biotech Ltd Identifier: NCT00851435    
Other Study ID Numbers: KB-101-002
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Keywords provided by Kenta Biotech Ltd:
Nosocomial pneumonia
Pseudomonas aeruginosa
Monoclonal antibody
Hospital-Acquired Pneumonia
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes