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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

July 22, 2023

Primary Completion Date

February 10, 2026

Study Completion Date

September 7, 2026

Conditions
Pneumonia, Bacterial
Interventions
DRUG

CAL02

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

DRUG

Placebo

Physiological 0.9% sodium chloride solution for iv administration

Trial Locations (90)

1935

FCRN Clinical Trial Centre, Vereeniging

3700

JSC Rustavi Central Hospital, Rustavi

6400

LTD Batumi Medical Center, Batumi

7130

Dr JM Engelbrecht Trial Site, Somerset West

15090

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, São José do Rio Preto

27157

Wake Forest Baptist Health Hospital, Winston-Salem

32610

UF Health Shands Hospital, Gainesville

44111

Cleveland Clinic Fairview Hospital, Cleveland

60611

Northwestern Memorial Hospital, Chicago

68198

University of Nebraska Medical Center, Omaha

77555

University of Texas Medical Branch, Galveston

93701

UCSF Hospital, Fresno

Unknown

Hospital Interzonal General de Agudo Dr Jose Pena, Bahía Blanca

Hospital Misericordia Nuevo Siglo, Córdoba

Hospital Central, Mendoza

Clinique Universitaire Saint Luc, Brussels

Clinique Saint Pierre, Ottignies

Chu-Ucl-Namur, Yvoir

Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu, Botucatu

Hospital do Servidor Publico Estadual, São Paulo

Foothills Hospital Medical Centre, Calgary

Peter Lougheed Centre, Calgary

Rockyview General Hospital, Calgary

South Health Campus Hospital, Calgary

Saint Paul's Hospital, Vancouver

Pontificia Universidad Catolica de Chile, Santiago

Centro de Investigacion Clinica de la Costa SAS, Barranquilla

Fundacion Cardioinfantil - Instituto de Cardiologia, Bogotá

Krajska Zdravotni, a.s., Teplice

Krajska Zdravotni, a.s., Ústí nad Labem

Oblastní nemocnice Kolín, a.s., nemocnice Středočeského kraje, Zizkova

CHD Vendee, La Roche-sur-Yon

CHU Angers, Angers

Centre Hospitalier Victor Dupouy, Argenteuil

Hopital Nord Franche Comte, Belfort

Hospital Fleyriat, Bourg-en-Bresse

Centre Hospitalier de Dieppe, Dieppe

Plateforme de Biologie Hospitalo-Universitaire, Dijon

Hopital Raymond Poincare, Garches

Pole Urgences Medecine Aigue CHU de Grenoble-Alpes, Grenoble

Hospital Dupuytren, Limoges

Centre Hospitalier de Melun-Senart, Melun

CHU de Nantes, Nantes

Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil, Strasbourg

Centre Hospitalier Bretagne Atlantique, Vannes

Thoracic General Hospital, Athens

University General Hospital Attikon, Athens

University General Hospital, Heraklion

Bekes Varmegyei Kozponti K6rhaz, Gyula

Szaboles-Szatmar-Bereg Varmegyei Oktatokorhaz, Nyíregyháza

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatov, Szentpeteri Kapu

Zala Varmegyei Szent Rafael Korbaz, Zalaegerszeg

Liepajas Regional Hospital, Liepāja

Pauls Stradins Clinical University Hospital, Riga

Vidzemes Hospital, Valmiera

Hospital Nacional III, Arequipa

Clinica Ricardo Palma, Lima

Clinica San Pablo-Sede Surco, Lima

Hospital Nacional Edgardo Rebagliati, Lima

Hospital de la Amistad, Piura

Pius Brinzeu County Emergency Clinical Hospital, Timișoara

Elias University Emergency Hospital, Bucharest

Fundeni Clinical Institute, Bucharest

Cluj County Emergency Clinical Hospital, Cluj-Napoca

Bihor County Emergency Clinical Hospital, Oradea

University Clinical Centre of Serbia, Belgrade

Institute for Pulmonary Diseases, Kamenitz

University Clinical Centre, Kragujevac

University Clinical Centre, Niš

Univerzitna nemocnica, Martin

Helen Joseph Academic Hospital, Johannesburg

Tygerberg Hospital, Cape Town

Ryexo Clinical Research, Pretoria

Hospital Universitari Vall d'Hebron, Barcelona

Parc Tauli Hospital Universitari, Barcelona

Hospital Clinico San Carlos, Madrid

Hospital Universitario Infanta Leonor, Madrid

C.H.U de Santiago de Compostela, Santiago de Compostela

Hospital Universitario de Tarragona Joan XXIII, Tarragona

Hospital Universitari Mutua Terrassa, Terrassa

Hospital Universitario de Toledo, Toledo

Hospital Universitario Dr Peset, Valencia

Hospital Clínico Universitario de Valladolid, Valladolid

C1199ABB

Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires

90880-480

Hospital Mae de Deus, Porto Alegre

0102

LLC Aleksandre Aladashvili Clinic, Tbilisi

0159

LTD Tbilisi Central Hospital, Tbilisi

0179

LTD Simon Khechinashvili University Hospital, Tbilisi

0180

The First Medical Center LTD, Tbilisi

0197

LTD N5 Clinical Hospital, Tbilisi

Sponsors
All Listed Sponsors
lead

Eagle Pharmaceuticals, Inc.

INDUSTRY

NCT05776004 - Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia | Biotech Hunter | Biotech Hunter