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Anti-infective Agent

CAL02 for Bacterial Pneumonia

Phase 2

Recruiting

Research Sponsored by Eagle Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial tests a drug's effectiveness in treating severe pneumonia in hospitalized patients who need critical care.

Who is the study for?

Adults over 18 with severe community-acquired bacterial pneumonia (SCABP) who were hospitalized within the last 48 hours and require critical care can join. They must weigh between 40-140 kg and give written consent. Excluded are those with certain types of pneumonia, a high SOFA score, prolonged IV antibiotic use for this condition, liver dysfunction, recent investigational study participation, or life-threatening medical conditions.Check my eligibility

What is being tested?

The trial is testing CAL02 in combination with standard treatments against a placebo plus standard treatments in patients with SCABP. The goal is to see if adding CAL02 improves outcomes for these critically ill patients.See study design

What are the potential side effects?

While specific side effects of CAL02 aren't listed here, participants may experience reactions related to the drug or its liposomal formulation. Standard care side effects will also apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I show signs of severe pneumonia, including symptoms, vital sign changes, or lab findings.

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I have severe pneumonia needing intensive care or mechanical help to breathe.

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I was diagnosed with a lung infection within 2 days of being admitted to the hospital.

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My weight is between 40 and 140 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy- clinical recovery

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Critical Care Management

Early Clinical Recovery

Hospital Stay

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CAL02 with Standard of CareExperimental Treatment1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Eagle Pharmaceuticals, Inc.Lead Sponsor

6 Previous Clinical Trials

734 Total Patients Enrolled

Valentin R Curt, MDStudy ChairEagle Pharmaceuticals, Inc.

Media Library

CAL02 (Anti-infective Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05776004 — Phase 2

Bacterial Pneumonia Research Study Groups: CAL02 with Standard of Care, Placebo

Bacterial Pneumonia Clinical Trial 2023: CAL02 Highlights & Side Effects. Trial Name: NCT05776004 — Phase 2

CAL02 (Anti-infective Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776004 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What dangers should be taken into consideration when administering CAL02 in combination with Standard of Care to individuals?

"Our internal assessment of CAL02 in combination with Standard Of Care gave it a score of 2, as there is evidence indicating its safety but none to show its efficacy."

Answered by AI

What is the scope of recruitment for this clinical trial?

"Affirmative. The clinicaltrials.gov page displays that this study is actively searching for participants; it was first posted on May 1st 2023 and updated lastly on May 15th 2023, with the need of 276 people from a single medical site."

Answered by AI

Is enrollment open for this medical experiment?

"Affirmative. According to the information provided by clinicaltrials.gov, this medical research project is currently recruiting participants that were initially posted on May 1st 2023 and was subsequently updated on May 15th 2023. A total of 276 individuals are being sought from a single location."

Answered by AI

What are the principal aims of this research endeavor?

"As per the research sponsor, Eagle Pharmaceuticals Inc., this clinical investigation has a primary outcome measure of efficacy-clinical recovery over 28 days. Secondary objectives include evaluating Sequential Organ Failure Assessment (SOFA) scores, the duration of critical care management and overall hospital stay in comparison to placebo administration. The SOFA score ranges from 0 - 24 with higher values indicating worse outcomes while hospital stays are measured by counting days until discharge occurs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776004.