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

This study has been completed.
Sponsor:
Information provided by:
Kenta Biotech Ltd
ClinicalTrials.gov Identifier:
NCT00851435
First received: February 25, 2009
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Pneumonia
Ventilator Associated Pneumonia
Biological: KBPA-101
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kenta Biotech Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To confirm the therapeutic plasma concentration of KBPA-101 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: February 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851435

Locations
Switzerland
Several sites in Switzerland, France, Belgium and Greece
Basel, Switzerland
Sponsors and Collaborators
Kenta Biotech Ltd
Investigators
Study Director: Violetta Georgescu Kenta Biotech Ltd
  More Information

No publications provided

Responsible Party: Violetta Georgescu, Kenta Biotech Ltd
ClinicalTrials.gov Identifier: NCT00851435     History of Changes
Other Study ID Numbers: KB-101-002
Study First Received: February 25, 2009
Last Updated: July 29, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Kenta Biotech Ltd:
Pneumonia
Nosocomial pneumonia
Pseudomonas aeruginosa
Monoclonal antibody
Hospital-Acquired Pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014