A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP
Community-acquired Pneumonia
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Recombinant human plasma gelsolin (rhu-pGSN), Severe community-acquired pneumonia (sCAP), Adjunctive therapy
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained from subject
- Domicile: home, assisted living, rehabilitation facility, or nursing home (as long as the prospective participant is capable of providing written informed consent)
- Duration of infection precipitating hospitalization by history <14 days
- Planned or actual admission to hospital with a primary diagnosis of CAP within 24 hours of presentation to the hospital
Primary admitting diagnosis of pneumonia supported by a compatible clinical presentation with a documented infiltrate consistent with pneumonia on chest radiograph or CT, as assessed by the admitting emergency-department (ED), clinic, or ward physician or equivalent caregiver
Recommended (not mandatory) guidance/discretionary criteria defining patients with CAP:
- At least 2 symptoms: difficulty breathing, cough, production of purulent sputum, chest pain
- At least 2 vital sign abnormalities: fever, tachycardia, tachypnea
- At least one finding of other clinical signs and laboratory abnormalities: hypoxemia, clinical evidence of pulmonary consolidation, an elevated total white blood cell (WBC) count or leukopenia
- Chest imaging showing new (or presumed new or worsening) infiltrates
- Receipt of antibiotic treatment prior to presentation does not exclude the patient
Exclusion Criteria:
- Pregnant or lactating women
- Intubation, vasopressor support, or admission to the intensive care unit (ICU) directly from the ED/office (fluids for responsive hypotension is not a reason for exclusion)
- Use of any investigational drug in the past 30 days
- Hospitalization during the last 30 days
- Residence within the last 30 days in long-term care facility where the patient remains persistently unable to participate in the routine activities of daily living
- Active underlying cancer treated with systemic chemotherapy or radiation therapy during the last 30 days
- Known or suspected immunosuppressive disease or therapy (including steroid use equivalent to prednisone ≥20 mg/day for >7 days or known advanced human immunodeficiency virus (HIV) infection with CD4 count ≤200/mm3; specific testing for HIV status or CD4 count is not required but can be done at the discretion of the caregivers)
- Active congestive heart failure, myocardial infarction, or pulmonary embolism; cardiopulmonary arrest in last 30 days
- Weight >100 kg
- Otherwise unsuitable for study participation in the opinion of the investigator
Sites / Locations
- Cairns Hospital
- Box Hill Hospital
- Footscray Hospital
- LTD Geo Hospitals, Mtskheta Multiprofile Medical Center
- JSC Rustavi Central Hospital
- LTD Central University Clinic After Academic N. Kipshidze
- LTD S. Khechinashvili University Hospital
- LTD 5th Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Single Dose 6 mg/kg
Multiple Dose 6 mg/kg
Multiple Dose 12 mg/kg
Multiple Dose 24 mg/kg
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg v. placebo (NSS) in addition to standard of care
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care