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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Pneumonia, Bacterial

In brief

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

Key facts

Study ID

NCT05776004

Run by

Eagle Pharmaceuticals, Inc.

People needed

276

Starts

2023-07-22

Expected to finish

2026-09-07

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Saint Paul's Hospital — Vancouver, Canada
• UCSF Hospital — Fresno, California, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Wake Forest Baptist Health Hospital — Winston-Salem, North Carolina, United States
• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Hospital Interzonal General de Agudo Dr Jose Pena — Bahía Blanca, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Hospital Misericordia Nuevo Siglo — Córdoba, Argentina
• Hospital Central — Mendoza, Argentina
• Clinique Universitaire Saint Luc — Brussels, Belgium
• Clinique Saint Pierre — Ottignies, Belgium
• Chu-Ucl-Namur — Yvoir, Belgium
• Hospital Mae de Deus — Porto Alegre, Rio Grande do Sul, Brazil
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, Brazil
• Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu — Botucatu, Brazil
• Hospital do Servidor Publico Estadual — São Paulo, Brazil
• Foothills Hospital Medical Centre — Calgary, Alberta, Canada
• Peter Lougheed Centre — Calgary, Alberta, Canada
• Rockyview General Hospital — Calgary, Alberta, Canada
• Pontificia Universidad Catolica de Chile — Santiago, Chile
• Centro de Investigacion Clinica de la Costa SAS — Barranquilla, Colombia
• South Health Campus Hospital — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.