Back to results

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

Primary Purpose

Pneumonia, Ventilator Associated Pneumonia

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

KBPA-101

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, Nosocomial pneumonia, Pseudomonas aeruginosa, Monoclonal antibody, Hospital-Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Several sites in Switzerland, France, Belgium and Greece

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KBPA-101, a monoclonal antibody

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

To confirm the therapeutic plasma concentration of KBPA-101

To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia

Full Information

NCT ID

NCT00851435

First Posted

February 25, 2009

Last Updated

July 29, 2009

Sponsor

Kenta Biotech Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00851435

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kenta Biotech Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Ventilator Associated Pneumonia

Keywords

Pneumonia, Nosocomial pneumonia, Pseudomonas aeruginosa, Monoclonal antibody, Hospital-Acquired Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KBPA-101, a monoclonal antibody

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

KBPA-101

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To confirm the therapeutic plasma concentration of KBPA-101

Time Frame

30 days

Title

To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Violetta Georgescu

Organizational Affiliation

Kenta Biotech Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Several sites in Switzerland, France, Belgium and Greece

City

Basel

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs