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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851435
• Other study ID #: KB-101-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 25, 2009
• Last updated: July 29, 2009
• Start date: February 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Kenta Biotech Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Biological:
• KBPA-101
1.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day

Locations

Country	Name	City	State
Switzerland	Several sites in Switzerland, France, Belgium and Greece	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Kenta Biotech Ltd

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To confirm the therapeutic plasma concentration of KBPA-101		30 days	No
Secondary	To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia		30 days	No