Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233207
Status:
TERMINATED
Last Update Posted:
2017-05-16
First Post:
2005-10-03
Brief Title:
IC14 Antibodies to Treat Individuals With Acute Lung Injury
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Acute Lung Injury Clinical Trials Incubator Unit
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to meet enrollment number to complete study study stopped June 30 2007
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II randomized double-blind placebo-controlled safety and efficacy study of a recombinant chimeric monoclonal antibody against CD14 IC14 in hospitalized patients with acute lung injury ALI
Detailed Description:
BACKGROUND
This study will use IC14 a recombinant chimeric monoclonal antibody mAb recognizing CD14 to block CD14 medicated cellular activation in patients with sepsis-induced ALI Research results of antibody interaction with CD14 suggest that CD14 has a central role in the recognition of bacterial products and the induction of innate immune responses Although beneficial when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful This study will implement strategies to block CD14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response mechanical ventilation days multiple organ failure and severity of organ dysfunction in patients with sepsis-induced ALI
DESIGN NARRATIVE
The primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at Days 2 and 3 and Days 6 to 8
The key secondary outcomes of this study will be 1 Worst Murray Lung Injury Score measured at Days 1 through 7 and Day 28 2 Worst Multiple Organ Dysfunction MOD Score Marshall measured at Days 1 through 7 and Day 28 3 Infections-nosocomial andor surgical site infections measured at Day 28 4 Ventilator-free days measured at Day 28 and 5 Mortality measured at Day 28
This study will use IC14 a recombinant chimeric monoclonal antibody mAb recognizing CD14 to block CD14 medicated cellular activation in patients with sepsis-induced ALI Research results of antibody interaction with CD14 suggest that CD14 has a central role in the recognition of bacterial products and the induction of innate immune responses Although beneficial when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful This study will implement strategies to block CD14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response mechanical ventilation days multiple organ failure and severity of organ dysfunction in patients with sepsis-induced ALI
DESIGN NARRATIVE
The primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at Days 2 and 3 and Days 6 to 8
The key secondary outcomes of this study will be 1 Worst Murray Lung Injury Score measured at Days 1 through 7 and Day 28 2 Worst Multiple Organ Dysfunction MOD Score Marshall measured at Days 1 through 7 and Day 28 3 Infections-nosocomial andor surgical site infections measured at Day 28 4 Ventilator-free days measured at Day 28 and 5 Mortality measured at Day 28
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL073996 | NIH | None | httpsreporternihgovquickSearchP50HL073996 |