A Phase 2 interventional study of IC14 in Respiratory Distress Syndrome, Adult and Lung Diseases, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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).
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 and/or surgical site infections (measured at Day 28); 4) Ventilator-free days (measured at Day 28); and 5) Mortality (measured at Day 28).
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 13 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Presence of ALI, defined as the following:
Exclusion Criteria:
Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8)
Worst Murray Lung Injury Score
Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28)
Infections-nosocomial and/or surgical site infections
Ventilator-free days
Mortality (measured at Day 28)
This study is terminated, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Washington