Clinical trial NCT05776004: Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
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)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Pneumonia, Bacterial
Keywords: Community-Acquired
Lead sponsor: Eagle Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptive, randomized, double-blind, placebo-controlled study
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Efficacy- clinical recovery
timeFrame: 28 days
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: Critical Care Management
timeFrame: 28 days
measure: Hospital Stay
timeFrame: 28 days
measure: Early Clinical Recovery
timeFrame: 5 days
measure: Organ Failure Assessment Scores
timeFrame: 7 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Hospital
state: California
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Bahía Blanca
country: Argentina
facility: Hospital Interzonal General de Agudo Dr Jose Pena
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Hospital Misericordia Nuevo Siglo
city: Mendoza
country: Argentina
facility: Hospital Central
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint Luc
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Yvoir
country: Belgium
facility: Chu-Ucl-Namur
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: Rio Grande Do Sul
city: São José Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: Sao Paulo
city: Botucatu
country: Brazil
facility: Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu
city: São Paulo
country: Brazil
facility: Hospital do Servidor Publico Estadual
city: Calgary
country: Canada
facility: Foothills Hospital Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Clinica de la Costa SAS
city: Bogotá
country: Colombia
facility: Fundacion Cardioinfantil - Instituto de Cardiologia
city: Teplice
country: Czechia
facility: Krajska Zdravotni, a.s.
city: Zizkova
country: Czechia
facility: Oblastní nemocnice Kolín, a.s., nemocnice Středočeského kraje
city: Ústí Nad Labem
country: Czechia
facility: Krajska Zdravotni, a.s.
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
state: Vendee
city: Angers
country: France
facility: CHU Angers
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Belfort
country: France
facility: Hopital Nord Franche Comte
city: Bourg-en-Bresse
country: France
facility: Hospital Fleyriat
city: Dieppe
country: France
facility: Centre Hospitalier de Dieppe
city: Dijon
country: France
facility: Plateforme de Biologie Hospitalo-Universitaire
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Grenoble
country: France
facility: Pole Urgences Medecine Aigue CHU de Grenoble-Alpes
city: Limoges
country: France
facility: Hospital Dupuytren
city: Melun
country: France
facility: Centre Hospitalier de Melun-Senart
city: Nantes
country: France
facility: CHU de Nantes
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Batumi
country: Georgia
facility: LTD Batumi Medical Center
city: Rust'avi
country: Georgia
facility: JSC Rustavi Central Hospital
city: Tbilisi
country: Georgia
facility: LLC Aleksandre Aladashvili Clinic
city: Tbilisi
country: Georgia
facility: LTD Tbilisi Central Hospital
city: Tbilisi
country: Georgia
facility: LTD Simon Khechinashvili University Hospital
city: Tbilisi
country: Georgia
facility: The First Medical Center LTD
city: Tbilisi
country: Georgia
facility: LTD N5 Clinical Hospital
city: Athens
country: Greece
facility: Thoracic General Hospital
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Heraklion
country: Greece
facility: University General Hospital
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti K6rhaz
city: Nyiregyhaza
country: Hungary
facility: Szaboles-Szatmar-Bereg Varmegyei Oktatokorhaz
city: Szentpeteri Kapu
country: Hungary
facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatov
city: Zalaegerszeg
country: Hungary
facility: Zala Varmegyei Szent Rafael Korbaz
city: Liepāja
country: Latvia
facility: Liepajas Regional Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Arequipa
country: Peru
facility: Hospital Nacional III
city: Lima
country: Peru
facility: Clinica Ricardo Palma
city: Lima
country: Peru
facility: Clinica San Pablo-Sede Surco
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati
city: Piura
country: Peru
facility: Hospital de la Amistad
city: Timişoara
country: Romania
facility: Pius Brinzeu County Emergency Clinical Hospital
state: Judet Timis
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Cluj-Napoca
country: Romania
facility: Cluj County Emergency Clinical Hospital
city: Oradea
country: Romania
facility: Bihor County Emergency Clinical Hospital
city: Belgrad
country: Serbia
facility: University Clinical Centre of Serbia
city: Kragujevac
country: Serbia
facility: University Clinical Centre
city: Niš
country: Serbia
facility: University Clinical Centre
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases
city: Martin
country: Slovakia
facility: Univerzitna nemocnica
city: Johannesburg
country: South Africa
facility: Helen Joseph Academic Hospital
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre
state: Gauteng
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Pretoria
country: South Africa
facility: Ryexo Clinical Research
city: Somerset West
country: South Africa
facility: Dr JM Engelbrecht Trial Site
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Parc Tauli Hospital Universitari
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Santiago De Compostela
country: Spain
facility: C.H.U de Santiago de Compostela
city: Tarragona
country: Spain
facility: Hospital Universitario de Tarragona Joan XXIII
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Valencia
country: Spain
facility: Hospital Universitario Dr Peset
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Eagle Pharmaceuticals, Inc.
name: Valentin R Curt, MD
role: STUDY_CHAIR
References: