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

NCT ID: NCT05776004

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-22
• Study Completion Date: 2026-09-07

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

Detailed 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.

Conditions

Pneumonia, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CAL02 with Standard of Care

CAL02 (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.

Group Type: EXPERIMENTAL

CAL02

Intervention Type: DRUG

CAL02 consists of a mixture of 2 liposomes and is a non-biological bacterial virulence neutralizer.

Placebo

Placebo 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Physiological 0.9% sodium chloride solution for iv administration

Interventions

CAL02

CAL02 consists of a mixture of 2 liposomes and is a non-biological bacterial virulence neutralizer.

Intervention Type: DRUG

Placebo

Physiological 0.9% sodium chloride solution for iv administration

Intervention Type: DRUG

Eligibility Criteria

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eagle Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentin R Curt, MD

Role: STUDY_CHAIR

Eagle Pharmaceuticals, Inc.

Locations

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

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, , Georgia

JSC Rustavi Central Hospital

Rustavi, , Georgia

LLC Aleksandre Aladashvili Clinic

Tbilisi, , Georgia

LTD Tbilisi Central Hospital

Tbilisi, , Georgia

LTD Simon Khechinashvili University Hospital

Tbilisi, , Georgia

The First Medical Center LTD

Tbilisi, , Georgia

LTD N5 Clinical Hospital

Tbilisi, , 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, South Africa

Tygerberg Hospital

Cape Town, , South Africa

Ryexo Clinical Research

Pretoria, , South Africa

Dr JM Engelbrecht Trial Site

Somerset West, , 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

Countries

United States; Argentina; Belgium; Brazil; Canada; Chile; Colombia; Czechia; France; Georgia; Greece; Hungary; Latvia; Peru; Romania; Serbia; Slovakia; South Africa; Spain

Other Identifiers

EGL-6535-C-2202

Identifier Type: -

Identifier Source: org_study_id