Status:
COMPLETED
A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP
Lead Sponsor:
BioAegis Therapeutics Inc.
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
A total of 32 patients hospitalized with CAP will be randomized sequentially into 4 ascending dosing levels. Each dosing cohort will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03466073
Start Date
August 28 2018
End Date
April 2 2019
Last Update
January 27 2020
Active Locations (8)
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1
Cairns Hospital
Cairns, Queensland, Australia, 4870
2
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
3
Footscray Hospital
Footscray, Victoria, Australia, 3011
4
LTD Geo Hospitals, Mtskheta Multiprofile Medical Center
Mtskheta, Georgia, 3300