Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around

Description

Summary

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)

Details

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.

Keywords

Pneumonia, Bacterial, Community-Acquired, Pneumonia, Bacterial Pneumonia, CAL02

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

Locations

  • UCSF Hospital accepting new patients
    Fresno California 93701 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68198 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eagle Pharmaceuticals, Inc.
ID
NCT05776004
Phase
Phase 2 Pneumonia Research Study
Study Type
Interventional
Participants
Expecting 276 study participants
Last Updated