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New Toxin-Neutralizing drug could speed recovery from severe pneumonia

NCT ID NCT05776004

Disease control Sponsor: Eagle Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding CAL02 to standard antibiotics helps people with severe community-acquired bacterial pneumonia recover faster. CAL02 is designed to neutralize toxins released by bacteria. About 276 hospitalized adults in critical care will receive either CAL02 or a placebo, and researchers will measure how quickly they get better and any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAL02 (a mixture of liposomes that neutralize bacterial toxins)
What this could lead to
If it works, CAL02 could become a new add-on treatment to help people with severe bacterial pneumonia recover faster and spend less time in intensive care.
What could go wrong
This is a mid-stage trial with 276 participants, so results are not yet proven. The drug may not improve outcomes or could cause side effects like infusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 276 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumonia - bacterial

Contacts and locations

Locations

  • Bekes Varmegyei Kozponti K6rhaz

    Gyula, Hungary

  • Bihor County Emergency Clinical Hospital

    Oradea, Romania

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatov

    Szentpeteri Kapu, Hungary

  • C.H.U de Santiago de Compostela

    Santiago de Compostela, Spain

  • CHD Vendee

    La Roche-sur-Yon, Vendee, France

  • CHU Angers

    Angers, France

  • CHU de Nantes

    Nantes, France

  • Centre Hospitalier Bretagne Atlantique

    Vannes, France

  • Centre Hospitalier Victor Dupouy

    Argenteuil, France

  • Centre Hospitalier de Dieppe

    Dieppe, France

  • Centre Hospitalier de Melun-Senart

    Melun, France

  • Centro de Investigacion Clinica de la Costa SAS

    Barranquilla, Colombia

  • Chu-Ucl-Namur

    Yvoir, Belgium

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio, 44111, United States

  • Clinica Ricardo Palma

    Lima, Peru

  • Clinica San Pablo-Sede Surco

    Lima, Peru

  • Clinique Saint Pierre

    Ottignies, Belgium

  • Clinique Universitaire Saint Luc

    Brussels, Belgium

  • Cluj County Emergency Clinical Hospital

    Cluj-Napoca, Romania

  • Dr JM Engelbrecht Trial Site

    Somerset West, 7130, South Africa

  • Elias University Emergency Hospital

    Bucharest, Romania

  • FCRN Clinical Trial Centre

    Vereeniging, Gauteng, 1935, South Africa

  • Foothills Hospital Medical Centre

    Calgary, Alberta, Canada

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090, Brazil

  • Fundacion Cardioinfantil - Instituto de Cardiologia

    Bogotá, Colombia

  • Fundeni Clinical Institute

    Bucharest, Romania

  • Helen Joseph Academic Hospital

    Johannesburg, Gauteng, South Africa

  • Hopital Nord Franche Comte

    Belfort, France

  • Hopital Raymond Poincare

    Garches, France

  • Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil

    Strasbourg, France

  • Hospital Central

    Mendoza, Argentina

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Dupuytren

    Limoges, France

  • Hospital Fleyriat

    Bourg-en-Bresse, France

  • 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 Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

  • Hospital Misericordia Nuevo Siglo

    Córdoba, Argentina

  • Hospital Nacional Edgardo Rebagliati

    Lima, Peru

  • Hospital Nacional III

    Arequipa, Peru

  • Hospital Universitari Mutua Terrassa

    Terrassa, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Dr Peset

    Valencia, Spain

  • Hospital Universitario Infanta Leonor

    Madrid, Spain

  • Hospital Universitario de Tarragona Joan XXIII

    Tarragona, Spain

  • Hospital Universitario de Toledo

    Toledo, Spain

  • Hospital de la Amistad

    Piura, Peru

  • Hospital do Servidor Publico Estadual

    São Paulo, Brazil

  • Institute for Pulmonary Diseases

    Kamenitz, Serbia

  • JSC Rustavi Central Hospital

    Rustavi, 3700, Georgia

  • Krajska Zdravotni, a.s.

    Teplice, Czechia

  • Krajska Zdravotni, a.s.

    Ústí nad Labem, Czechia

  • LLC Aleksandre Aladashvili Clinic

    Tbilisi, 0102, Georgia

  • LTD Batumi Medical Center

    Batumi, 6400, Georgia

  • LTD N5 Clinical Hospital

    Tbilisi, 0197, Georgia

  • LTD Simon Khechinashvili University Hospital

    Tbilisi, 0179, Georgia

  • LTD Tbilisi Central Hospital

    Tbilisi, 0159, Georgia

  • Liepajas Regional Hospital

    Liepāja, Latvia

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

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

    Zizkova, Czechia

  • Parc Tauli Hospital Universitari

    Barcelona, Spain

  • Pauls Stradins Clinical University Hospital

    Riga, Latvia

  • Peter Lougheed Centre

    Calgary, Alberta, Canada

  • Pius Brinzeu County Emergency Clinical Hospital

    Timișoara, Judet Timis, Romania

  • Plateforme de Biologie Hospitalo-Universitaire

    Dijon, France

  • Pole Urgences Medecine Aigue CHU de Grenoble-Alpes

    Grenoble, France

  • Pontificia Universidad Catolica de Chile

    Santiago, Chile

  • Rockyview General Hospital

    Calgary, Alberta, Canada

  • Ryexo Clinical Research

    Pretoria, South Africa

  • Saint Paul's Hospital

    Vancouver, Canada

  • South Health Campus Hospital

    Calgary, Alberta, Canada

  • Szaboles-Szatmar-Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, Hungary

  • The First Medical Center LTD

    Tbilisi, 0180, Georgia

  • Thoracic General Hospital

    Athens, Greece

  • Tygerberg Hospital

    Cape Town, South Africa

  • UCSF Hospital

    Fresno, California, 93701, United States

  • UF Health Shands Hospital

    Gainesville, Florida, 32610, United States

  • Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu

    Botucatu, Brazil

  • University Clinical Centre

    Kragujevac, Serbia

  • University Clinical Centre

    Niš, Serbia

  • University Clinical Centre of Serbia

    Belgrade, Serbia

  • University General Hospital

    Heraklion, Greece

  • University General Hospital Attikon

    Athens, Greece

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • Univerzitna nemocnica

    Martin, Slovakia

  • Vidzemes Hospital

    Valmiera, Latvia

  • Wake Forest Baptist Health Hospital

    Winston-Salem, North Carolina, 27157, United States

  • Zala Varmegyei Szent Rafael Korbaz

    Zalaegerszeg, Hungary

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