A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAL02 ADMINISTERED INTRAVENOUSLY IN ADDITION TO STANDARD OF CARE IN SUBJECTS WITH SEVERE COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (SCABP)

Eagle Pharmaceuticals, Inc.0 个研究点目标入组 0 人开始时间: 2023年11月15日最近更新: 2024年8月20日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Eagle Pharmaceuticals, Inc.

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Males or females =18 years old
•Body weight 40 to 140 kg (88 to 308 lb), inclusive
•3-Clinical diagnosis of CABP (diagnosed =48 hours after hospital admission), defined as a. At least two clinical symptoms: i. Difficulty breathing
•iii. Production of purulent sputum
•iv. Chest pain
•b. At least two vital sign abnormalities: i. Fever (=38°C, 100.4°F)
•ii. Hypothermia (<36.0°C, 96.8°F)
•iii. Hypotension (<90 mm Hg systolic)
•iv. Tachycardia (>100 bpm)
•v. Tachypnea (>20 rpm)
•c. At least one finding of other clinical signs/laboratory abnormalities: i. Hypoxemia oxygen saturation (pulse oximeter <88%)
•ii. Clinical evidence of pulmonary consolidation
•iii. Elevated total white blood cell (WBC) count (=10,000 cells/mm3) or leukopenia (<4000 cells/mm3)
•d. Radiographic evidence in support of pneumonia with likely bacterial origin
•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 of protocol document]) 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

排除标准

•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
•Moribund clinical conditions at the time of screening or time of the first IMP infusion
•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 per protocol defined SCABP 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)
•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
•Renal Replacement Therapy (eg, hemofiltration, hemodialysis, cytokine filters, etc.)
•Known hypersensitivity 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
•11-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 of protocol document) (Jentzer 2018) or
•2 vasopressors at >0.1 µg/kg/min norepinephrine equivalent (Appendix 2 of protocol document) or
•>2 vasopressors at any dose

研究者

发起方

Eagle Pharmaceuticals, Inc.

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