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

NCT00851435 | Completed Phase 1

• 1 other identifier: KB-101-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Ventilator Associated Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (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.

  30 days

Secondary Outcomes (2)

• 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

Study Arms (1)

KBPA-101, a monoclonal antibody

EXPERIMENTAL

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

Biological: KBPA-101

Interventions

KBPA-101 BIOLOGICAL

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

KBPA-101, a monoclonal antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenta Biotech Ltd: lead

Study Sites (1)

Several sites in Switzerland, France, Belgium and Greece

Basel, Switzerland

Location

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Violetta Georgescu

  Kenta Biotech Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

CH (1)