Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT00851435
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00851435
Study Brief:
Protocol Section:
NCT00851435