Phase 2 Study of CAL02 plus Standard of Care in Severe Community-Acquired Bacterial Pneumonia (SCABP)
- Conditions
- SEVERE COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (SCABP)MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumonia Class: 10021881Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- CTIS2022-502049-91-00
- Lead Sponsor
- Eagle Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 265
Males or females =18 years old, Body weight 40 to 140 kg (88 to 308 lb), inclusive, Clinical diagnosis of CABP (diagnosed =48 hours after hospital admission), Presence of at least one of the following severity criteria, based on protocol defined SCABP: a. Respiratory failure requiring invasive mechanical ventilation support b. Respiratory failure requiring non-invasive positive pressure ventilation support (eg, continuous positive airway pressure [C-PAP], bi-level positive airway pressure [Bi-PAP]) and partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) =250 mm Hg, excluding home setting non-invasive positive pressure ventilation support c. Respiratory failure requiring high-flow oxygen defined as >40 L/min and PaO2/FiO2 ratio =250 mm Hg d. Septic shock requiring treatment with vasopressors at therapeutic doses (defined as >0.07 µg/kg/min norepinephrine equivalent [Appendix 2]) for at least 2 hours to maintain or attempt to maintain mean arterial pressure =65 mm Hg after adequate fluid resuscitation, Onset of severity criteria <48 hours from diagnosis of CABP or upon discussion with medical monitor, Requires critical care for management of SCABP, Written informed consent obtained from subject or legally acceptable representative, as per the local guidelines, before any study-specific assessment is performed; assessments performed as standard of care may be accepted for study purposes
Subjects with ventilator-associated pneumonia, aspiration pneumonia, hospital-acquired pneumonia, healthcare-associated pneumonia (HCAP), suspected or confirmed fungal pneumonia, or viral pneumonia (viral coinfection may be exempted subject to medical monitor discussion) (HCAP definition: hospitalization for 2 days or more within the preceding 90 days, residence in a nursing home or extended care facility, the use of home infusion therapy [including antibiotics], receipt of chronic dialysis within 30 days, home wound care and a history of infection with a multidrug-resistant pathogen in a family member), Moribund clinical conditions at the time of screening or time of the first IMP infusion, Refractory septic shock at the time of the randomization, as defined by the inability to maintain mean arterial pressure =65 mm Hg despite IV fluids and use of any of the following: • Any vasopressor at >0.4 µg/kg/min norepinephrine equivalent (Appendix 2) (Jentzer 2018) or • 2 vasopressors at >0.1 µg/kg/min norepinephrine equivalent (Appendix 2) or • >2 vasopressors at any dose, Subject has any medical disease (acute, subacute, intermittent, or chronic) or condition (eg, severely immune compromised) that, in the opinion of the investigator, compromises the subject’s safety or compromises the interpretation of the results, Nursing and pregnant women (defined as the state after conception until the termination of gestation, screened in all women of childbearing potential with a urine dipstick test and, if positive, confirmed by a human chorionic gonadotropin [hCG] blood test), Women of childbearing potential and non-surgically sterile male subjects who are sexually active and not willing to use an effective contraception from the time of consent until 30 days after the last dose of IMP unless local regulations require otherwise. Postmenopausal women are allowed to participate, More than 12 hours from the diagnosis of SCABP, SOFA score >12 points and cumulative points from central nervous system + liver function+coagulation =4 points at diagnosis of SCABP, Subject received IV antibiotics for CABP/SCABP for >48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administered, Severe renal impairment as determined by estimated serum creatinine clearance of <30 mL/min according to the Cockcroft-Gault equation renal replacement therapy (eg, hemofiltration, hemodialysis, cytokine filters, etc.), or extracorporeal membrane oxygenation (ECMO) at the time of screening or the first IMP infusion, Known hypersensitivity to egg, egg components, or to liposomal formulations, End-stage neuromuscular disorders, tracheostomy, known bronchial obstruction (except for chronic obstructive pulmonary disease, asthma, emphysema, and non-cystic fibrosis bronchiectasis), post-obstructive aspiration pneumonia, cystic fibrosis, known or suspected Pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary or metastatic malignancy in the lungs, Current or recent participation in an investigational study (within 30 days of screening, or 5 half-lives of the investigational compound, whichever is longer), Known liver dysfunction, chronic liver disease with Child Pugh C or esophageal varices
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method