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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Ventilator Associated Pneumonia
• Intervention / Treatment: Biological: KBPA-101

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • Several sites in Switzerland, France, Belgium and Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To confirm the therapeutic plasma concentration of KBPA-101	30 days
To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia	30 days

Collaborators and Investigators

• Sponsor: Kenta Biotech Ltd
• Investigators: Study Director: Violetta Georgescu, Kenta Biotech Ltd

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: February 25, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (ESTIMATE): February 26, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 29, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Pneumonia; Pseudomonas aeruginosa; Nosocomial pneumonia; Hospital-Acquired Pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: KB-101-002