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NCT05776004 · ClinicalTrials.gov registry record · Phase 2
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
A Phase 2 study of Pneumonia, Bacterial, sponsored by Eagle Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 276
- Enrollment target
- 20
- Study locations
NCT05776004: Active Phase 2 study of Pneumonia, Bacterial, sponsored by Eagle Pharmaceuticals.
NCT05776004 is a Phase 2 study of Pneumonia, Bacterial that is active but no longer recruiting, run by Eagle Pharmaceuticals. The registered enrollment target is 276 participants, below the 1,310-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05776004, a Phase 2 study of Pneumonia, Bacterial, is active but no longer recruiting, sponsored by Eagle Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 276 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2023-07-22 |
| Est. Completion | 2026-09-07 |
| Phase | Phase 2 |
What the registry record for NCT05776004 still lists
NCT05776004 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 1,310-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (79% lower).
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.
NCT05776004 names 20 study sites across 12 states, led by Other, Buenos Aires, Alberta.
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.
What interventions are being tested in trial NCT05776004?
The interventions under investigation include: Placebo (DRUG), CAL02 (DRUG).
Who is sponsoring clinical trial NCT05776004?
This trial is sponsored by Eagle Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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