Last updated 4 days ago
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
276 patients around the world
Available in United States, Brazil
Subjects diagnosed with SCABP and requiring critical care measures, will receive either 2
intravenous infusions of CAL02 (13.7 to 24 mg/kg bracketed dose by weight), administered
24-26 hours apart or 2 intravenous infusions of placebo. Additionally, all subjects will
receive standard of care (SOC) therapy for SCABP, according to scientific guidelines.
Critical care measures provide intensive and specialized medical and nursing care, a
capacity for continuous monitoring 24 hours/day, and multiple modalities of physiologic
organ support to sustain life in seriously/critically ill patients.
Eagle Pharmaceuticals, Inc.
1Research sites
276Patients around the world
This study is for people with
Pneumonia
Bacterial pneumonia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- male or females older than 18 years oldBody Weight 40 - 140 kgclinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital admissionpresence of at least one of the protocol defined SCABP severity criteria:at least two clinical symptomsat least 2 vital sign abnormalitiesat least one finding of other clinical signs/laboratory abnormalitiesradiographic evidence in support of pneumonia with likely bacterial originpresence of at least one of the following severity criteria based on protocol defined SCABP:respiratory failure requiring invasive mechanical ventilation supportrespiratory failure requiring non-invasive positive pressure ventilation supportrespiratory failure requiring high-flow oxygenseptic shock requiring treatment with vasopressors at therapeutic doses for at least 2 hoursrequires critical care for management of SCABPonset of severity criteria less than 48 hours from diagnosis of CABP or upon discussion with medical monitorwritten informed consent before any study-specific assessment is performed
- Subjects in the hospital who meet any of the following criteria at screening and before study drug administration:subjects with ventilator-associated pneumonia, aspiration pneumonia, fungal pneumonia, viral pneumonia (viral coinfection may be exempted subject to discussion with medical monitor)subjects more than 12 hours from the diagnosis of SCABPSOFA score greater than 12 pointssubject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administeredrenal replacement therapyknown hypersensitivity to liposomal formulationsend-stage neuromuscular disorders, tracheostomy, known bronchial obstruction, post-operative aspiration pneumonia, cystic fibrosis, known or suspected pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary or metastatic malignancy in the lungscurrent 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 varicesmoribund clinical conditions at the time of screening or time of the first study medication infusionrefractory septic shock at the time of randomizationsubject has any medical disease or condition that, in the opinion of the investigator, compromises the subject's safety or compromises the interpretation of resultsnursing and pregnant womenwomen of childbearing potential and non-surgically sterile males
Sites
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
SponsorEagle Pharmaceuticals, Inc.
Conditions
Bacterial pneumonia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05776004
