ACTIVE_NOT_RECRUITING

Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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)

Quick Facts

Study Start:2023-07-22

Study Completion:2026-09-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05776004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Valentin R Curt, MD

STUDY_CHAIR

Eagle Pharmaceuticals, Inc.

Study Locations (Sites)

UCSF Hospital

Fresno, California, 93701

United States

UF Health Shands Hospital

Gainesville, Florida, 32610

United States

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Wake Forest Baptist Health Hospital

Winston-Salem, North Carolina, 27157

United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111

United States

University of Texas Medical Branch

Galveston, Texas, 77555

United States

Collaborators and Investigators

Sponsor: Eagle Pharmaceuticals, Inc.

Valentin R Curt, MD, STUDY_CHAIR, Eagle Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-22

Study Completion Date2026-09-07

Study Record Updates

Study Start Date2023-07-22

Study Completion Date2026-09-07

Terms related to this study

Keywords Provided by Researchers

Community-Acquired

Additional Relevant MeSH Terms

Pneumonia, Bacterial