Pneumonia, BacterialPhase 2NCT05776004
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
A Phase 2 study testing CAL02 in people with Pneumonia, Bacterial, run by Eagle Pharmaceuticals, Inc. at 90 sites in 19 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- CAL02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 90 sitesin 19 countries
- Study dates
- 22 Jul 2023to 7 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 31Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
90 sites in 19 countries.
90 sites in 19 countries
France14 sites
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
CHD Vendee
La Roche-sur-Yon, Vendee
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
Spain10 sites
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
United States7 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
UCSF Hospital
Fresno, California, 93701
UF Health Shands Hospital
Gainesville, Florida, 32610
University of Texas Medical Branch
Galveston, Texas, 77555
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Wake Forest Baptist Health Hospital
Winston-Salem, North Carolina, 27157
Georgia7 sites
LTD Batumi Medical Center
Batumi, 6400
JSC Rustavi Central Hospital
Rustavi, 3700
LLC Aleksandre Aladashvili Clinic
Tbilisi, 0102
LTD Tbilisi Central Hospital
Tbilisi, 0159
LTD Simon Khechinashvili University Hospital
Tbilisi, 0179
The First Medical Center LTD
Tbilisi, 0180
LTD N5 Clinical Hospital
Tbilisi, 0197
Canada5 sites
Foothills Hospital Medical Centre
Calgary, Alberta
Peter Lougheed Centre
Calgary, Alberta
Rockyview General Hospital
Calgary, Alberta
South Health Campus Hospital
Calgary, Alberta
Saint Paul's Hospital
Vancouver
Peru5 sites
Hospital Nacional III
Arequipa
Clinica Ricardo Palma
Lima
Clinica San Pablo-Sede Surco
Lima
Hospital Nacional Edgardo Rebagliati
Lima
Hospital de la Amistad
Piura
Romania5 sites
Elias University Emergency Hospital
Bucharest
Fundeni Clinical Institute
Bucharest
Cluj County Emergency Clinical Hospital
Cluj-Napoca
Bihor County Emergency Clinical Hospital
Oradea
Pius Brinzeu County Emergency Clinical Hospital
Timișoara, Judet Timis
South Africa5 sites
Tygerberg Hospital
Cape Town
Helen Joseph Academic Hospital
Johannesburg, Gauteng
Ryexo Clinical Research
Pretoria
Dr JM Engelbrecht Trial Site
Somerset West, 7130
FCRN Clinical Trial Centre
Vereeniging, Gauteng, 1935
Argentina4 sites
Hospital Interzonal General de Agudo Dr Jose Pena
Bahía Blanca, Buenos Aires
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB
Hospital Misericordia Nuevo Siglo
Córdoba
Hospital Central
Mendoza
Brazil4 sites
Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu
Botucatu
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90880-480
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090
Hospital do Servidor Publico Estadual
São Paulo
Hungary4 sites
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
Serbia4 sites
University Clinical Centre of Serbia
Belgrade
Institute for Pulmonary Diseases
Kamenitz
University Clinical Centre
Kragujevac
University Clinical Centre
Niš
Belgium3 sites
Clinique Universitaire Saint Luc
Brussels
Clinique Saint Pierre
Ottignies
Chu-Ucl-Namur
Yvoir
Czechia3 sites
Krajska Zdravotni, a.s.
Teplice
Krajska Zdravotni, a.s.
Ústí nad Labem
Oblastní nemocnice Kolín, a.s., nemocnice Středočeského kraje
Zizkova
Greece3 sites
Thoracic General Hospital
Athens
University General Hospital Attikon
Athens
University General Hospital
Heraklion
Latvia3 sites
Liepajas Regional Hospital
Liepāja
Pauls Stradins Clinical University Hospital
Riga
Vidzemes Hospital
Valmiera
Colombia2 sites
Centro de Investigacion Clinica de la Costa SAS
Barranquilla
Fundacion Cardioinfantil - Instituto de Cardiologia
Bogotá
About this study
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)
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
Read the 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
- Being tested
- CAL02, Placebo
- Keywords
- Community-Acquired
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAL02Drug
CAL02 consists of a mixture of 2 liposomes and is a non-biological bacterial virulence neutralizer.
PlaceboDrug
Physiological 0.9% sodium chloride solution for iv administration
| Study group | Role | What they receive |
|---|---|---|
| CAL02 with Standard of Care | Experimental | 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. Receives: Drug: CAL02 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Secondary outcomes (4)
Critical Care Management
To evaluate the effect of CAL02 administration on the duration of critical care management compared to placebo. The time (days) participant remains in hospital critical care from randomization until discharge will be measured.
Measured: 28 days
Hospital Stay
To evaluate the effect of CAL02 administration on the duration of overall hospital stay compared to placebo. The time (days) participant remains in hospital from randomization until discharge will be measured.
Measured: 28 days
Early Clinical Recovery
To evaluate the effect of CAL02 administration on early clinical recovery (by Day 5) compared to placebo. The number of participants who achieve clinical recovery by Day 5 will be assessed; clinical recovery 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.
Measured: 5 days
Organ Failure Assessment Scores
To evaluate the effects of CAL02 administration on Sequential Organ Failure Assessment (SOFA) scores compared to placebo. The minimum total score is 0 and the maximum total score is 24. A higher total SOFA score indicates worse outcome.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start22 Jul 2023
- Primary completion10 Feb 2026 (estimated)
- Study completion7 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive, randomized, double-blind, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valentin R Curt, MD, Study chair, Eagle Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776004
- Sponsor's protocol ID
- EGL-6535-C-2202
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05776004
- Acronym / sponsor ID
- EGL-6535-C-2202
- Conditions
- Pneumonia, Bacterial
- Keywords
- Community-Acquired
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Eagle Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 7 Sep 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Adaptive, randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| CAL02 with Standard of Care | Experimental | Drug: CAL02CAL02 (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 comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAL02CAL02 consists of a mixture of 2 liposomes and is a non-biological bacterial virulence neutralizer. | Drug | CAL02 with Standard of Care |
| PlaceboPhysiological 0.9% sodium chloride solution for iv administration | Drug | Placebo |
Primary outcome
Efficacy- clinical recovery
Time frame: 28 days
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.
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 days
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.
4 secondary outcomes
Critical Care Management
Time frame: 28 days
Hospital Stay
Time frame: 28 days
Early Clinical Recovery
Time frame: 5 days
Organ Failure Assessment Scores
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin R Curt, MD study chair
Eagle Pharmaceuticals, Inc.
90 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAL02 in people with Pneumonia, Bacterial, run by Eagle Pharmaceuticals, Inc. at 90 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in France, Spain, United States, Georgia, Canada and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy- clinical recovery (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.