A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma gelsolin (rhu-pGSN) Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired Pneumonia (CAP)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
✕. 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