Lung Diseases Clinical Trial
Official title:
Acute Lung Injury Clinical Trials Incubator Unit
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).
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