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ACTIVE NOT RECRUITING Phase 2

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

NCT05776004 · View on ClinicalTrials.gov ↗

Study 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

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG CAL02

Study Locations (20)

Other

  • 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

Buenos Aires

  • Hospital Interzonal General de Agudo Dr Jose Pena — Bahía Blanca
  • Hospital Italiano de Buenos Aires — Ciudad Autonoma de Buenos Aires

Alberta

  • Foothills Hospital Medical Centre — Calgary
  • Peter Lougheed Centre — Calgary

California

  • UCSF Hospital — Fresno

Florida

  • UF Health Shands Hospital — Gainesville

Illinois

  • Northwestern Memorial Hospital — Chicago

Nebraska

  • University of Nebraska Medical Center — Omaha

North Carolina

  • Wake Forest Baptist Health Hospital — Winston-Salem

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2023-07-22
Est. Completion 2026-09-07
Phase Phase 2

Sponsor

Eagle Pharmaceuticals

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05776004

The ClinicalTrials.gov registry entry for NCT05776004 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eagle Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pneumonia, Bacterial appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05776004 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Buenos Aires, Alberta. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05776004 about?

NCT05776004 is a clinical study titled "Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia". 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

What is the current status of trial NCT05776004?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 276 participants. The study started on 2023-07-22. Estimated completion is 2026-09-07.

What conditions does trial NCT05776004 study?

This clinical trial studies the following conditions: Pneumonia, Bacterial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05776004?

The interventions under investigation include: Placebo (DRUG), CAL02 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05776004?

This trial is sponsored by Eagle Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05776004 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Nebraska, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial