Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
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)
1 other identifier
interventional
276
19 countries
90
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2023
Typical duration for phase_2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
July 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2026
ExpectedJanuary 28, 2026
January 1, 2026
2.6 years
February 14, 2023
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy- clinical recovery
To evaluate the effect of CAL02 administration on clinical recovery compared to placebo. The time (days) to clinical recovery will be measured, as defined by the day all disease severity criteria which led to SCABP diagnosis per protocol at randomization and any new severity criteria which occurred after randomization are resolved, and no repeat or additional severity criteria are met within 24 hours after clinical recovery.
28 days
Incidence of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of CAL02 versus placebo. The number of participants with treatment-emergent adverse events including IV infusion-related reactions, and the number of participants with study drug dosing interruptions and discontinuations will be measured.
28 days
Secondary Outcomes (4)
Critical Care Management
28 days
Hospital Stay
28 days
Early Clinical Recovery
5 days
Organ Failure Assessment Scores
7 days
Study Arms (2)
CAL02 with Standard of Care
EXPERIMENTALCAL02 (a mixture of 2 liposomal components, both empty, unilamellar, liposomes) will be administered as 2, IV infusions, 24 - 26 hours apart in addition to Standard of Care therapy for SCABP, according to scientific guidelines. CAL02 infusions will be administered over a 1 -2 hour period.
Placebo
PLACEBO COMPARATORPlacebo will be administered as 2, IV infusions, 24 - 26 hours apart in addition to Standard of Care therapy for SCABP, according to scientific guidelines. Placebo will be prepared and administered following the same infusion protocol as CAL02. Placebo infusions will be administered over a 1 to 2 hour period.
Interventions
Eligibility Criteria
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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
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
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, C1199ABB, 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, 90880-480, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090, 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
South Health Campus Hospital
Calgary, Alberta, Canada
Saint Paul's Hospital
Vancouver, Canada
Pontificia Universidad Catolica de Chile
Santiago, Chile
Centro de Investigacion Clinica de la Costa SAS
Barranquilla, Colombia
Fundacion Cardioinfantil - Instituto de Cardiologia
Bogotá, Colombia
Krajska Zdravotni, a.s.
Teplice, Czechia
Krajska Zdravotni, a.s.
Ústí nad Labem, Czechia
Oblastní nemocnice Kolín, a.s., nemocnice Středočeského kraje
Zizkova, Czechia
CHD Vendee
La Roche-sur-Yon, Vendee, France
CHU Angers
Angers, France
Centre Hospitalier Victor Dupouy
Argenteuil, France
Hopital Nord Franche Comte
Belfort, France
Hospital Fleyriat
Bourg-en-Bresse, France
Centre Hospitalier de Dieppe
Dieppe, France
Plateforme de Biologie Hospitalo-Universitaire
Dijon, France
Hopital Raymond Poincare
Garches, France
Pole Urgences Medecine Aigue CHU de Grenoble-Alpes
Grenoble, France
Hospital Dupuytren
Limoges, France
Centre Hospitalier de Melun-Senart
Melun, France
CHU de Nantes
Nantes, France
Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil
Strasbourg, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
LTD Batumi Medical Center
Batumi, 6400, Georgia
JSC Rustavi Central Hospital
Rustavi, 3700, Georgia
LLC Aleksandre Aladashvili Clinic
Tbilisi, 0102, Georgia
LTD Tbilisi Central Hospital
Tbilisi, 0159, Georgia
LTD Simon Khechinashvili University Hospital
Tbilisi, 0179, Georgia
The First Medical Center LTD
Tbilisi, 0180, Georgia
LTD N5 Clinical Hospital
Tbilisi, 0197, Georgia
Thoracic General Hospital
Athens, Greece
University General Hospital Attikon
Athens, Greece
University General Hospital
Heraklion, Greece
Bekes Varmegyei Kozponti K6rhaz
Gyula, Hungary
Szaboles-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatov
Szentpeteri Kapu, Hungary
Zala Varmegyei Szent Rafael Korbaz
Zalaegerszeg, Hungary
Liepajas Regional Hospital
Liepāja, Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Vidzemes Hospital
Valmiera, Latvia
Hospital Nacional III
Arequipa, Peru
Clinica Ricardo Palma
Lima, Peru
Clinica San Pablo-Sede Surco
Lima, Peru
Hospital Nacional Edgardo Rebagliati
Lima, Peru
Hospital de la Amistad
Piura, Peru
Pius Brinzeu County Emergency Clinical Hospital
Timișoara, Judet Timis, Romania
Elias University Emergency Hospital
Bucharest, Romania
Fundeni Clinical Institute
Bucharest, Romania
Cluj County Emergency Clinical Hospital
Cluj-Napoca, Romania
Bihor County Emergency Clinical Hospital
Oradea, Romania
University Clinical Centre of Serbia
Belgrade, Serbia
Institute for Pulmonary Diseases
Kamenitz, Serbia
University Clinical Centre
Kragujevac, Serbia
University Clinical Centre
Niš, Serbia
Univerzitna nemocnica
Martin, Slovakia
Helen Joseph Academic Hospital
Johannesburg, Gauteng, South Africa
FCRN Clinical Trial Centre
Vereeniging, Gauteng, 1935, South Africa
Tygerberg Hospital
Cape Town, South Africa
Ryexo Clinical Research
Pretoria, South Africa
Dr JM Engelbrecht Trial Site
Somerset West, 7130, South Africa
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Parc Tauli Hospital Universitari
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
C.H.U de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario de Tarragona Joan XXIII
Tarragona, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Spain
Hospital Universitario de Toledo
Toledo, Spain
Hospital Universitario Dr Peset
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Valentin R Curt, MD
Eagle Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Placebo-controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2023
First Posted
March 20, 2023
Study Start
July 22, 2023
Primary Completion
February 10, 2026
Study Completion (Estimated)
September 7, 2026
Last Updated
January 28, 2026
Record last verified: 2026-01