Phase 2 Study of CAL02 plus Standard of Care in Severe Community-Acquired Bacterial Pneumonia (SCABP
-
StatusAccepting Candidates
-
Age18 Years - N/A
-
SexesAll
-
Healthy VolunteersNo
Objective
This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures
Description
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.
Details
Full study title | 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) |
Protocol number | OCR44711 |
ClinicalTrials.gov ID | NCT05776004 |
Phase | Phase 2 |
Eligibility
Inclusion Criteria:
male or females older than 18 years old
Body Weight 40 * 140 kg;
clinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital admission;
presence of at least one of the protocol defined SCABP severity criteria:
at least two clinical symptoms
at least 2 vital sign abnormalities
at least one finding of other clinical signs/laboratory abnormalities
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:
respiratory failure requiring invasive mechanical ventilation support
respiratory failure requiring non-invasive positive pressure ventilation support
respiratory failure requiring high-flow oxygen
septic shock requiring treatment with vasopressors at therapeutic doses for at least 2 hours
requires critical care for management of SCABP
onset of severity criteria less than 48 hours from diagnosis of CABP or upon discussion with medical monitor
written informed consent before any study-specific assessment is performed
Exclusion Criteria: 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 SCABP;
SOFA score greater than 12 points
subject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administered
renal replacement therapy
known hypersensitivity to liposomal formulations
end-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 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
moribund clinical conditions at the time of screening or time of the first study medication infusion
refractory septic shock at the time of randomization
subject has any medical disease or condition that, in the opinion of the investigator, compromises the subject's safety or compromises the interpretation of results
nursing and pregnant women
women of childbearing potential and non-surgically sterile males
Lead researcher
-
Nicole M Iovine, MD, PhDInfectious Disease Specialist
Participate in a study
Here are some general steps to consider when participating in a research study:
-
Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
-
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
-
Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
-
Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.