CAL02 with Standard of Care for Bacterial Pneumonia

Northwestern Memorial Hospital, Chicago, IL
Bacterial PneumoniaCAL02 - Drug
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Bacterial Pneumonia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 28 days

28 days
Critical Care Management
Efficacy- clinical recovery
Hospital Stay
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
5 days
Early Clinical Recovery
7 days
Organ Failure Assessment Scores

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

CAL02 with Standard of Care
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

276 Total Participants · 2 Treatment Groups

Primary Treatment: CAL02 with Standard of Care · Has Placebo Group · Phase 2

CAL02 with Standard of Care
Drug
Experimental Group · 1 Intervention: CAL02 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days

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.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.