We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

IC14 Antibodies to Treat Individuals With Acute Lung Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00233207
Recruitment Status : Terminated (Unable to meet enrollment number to complete study, study stopped June 30, 2007)
First Posted : October 5, 2005
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Washington

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).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Lung Diseases Drug: IC14 Phase 2

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 and/or surgical site infections (measured at Day 28); 4) Ventilator-free days (measured at Day 28); and 5) Mortality (measured at Day 28).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Acute Lung Injury Clinical Trials Incubator Unit
Study Start Date : September 2005
Study Completion Date : June 2007





Primary Outcome Measures :
  1. Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8)

Secondary Outcome Measures :
  1. Worst Murray Lung Injury Score
  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
  4. Ventilator-free days
  5. Mortality (measured at Day 28)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of ALI, defined as the following:

    1. Acute onset (less than 28 days from study entry)
    2. PaO2/FiO2 of less than 300
    3. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
    4. Requirement for positive pressure ventilation via endotracheal tube
    5. No clinical evidence of left atrial hypertension
  • Clinical indication for antimicrobial therapy at the time of randomization
  • Anticipated duration of mechanical ventilation greater than 48 hours

Exclusion Criteria:

  • Treatment with a drug or device within 30 days prior to study entry that has not received regulatory approval at the time of study entry
  • Does not meet safety criteria for bronchoscopic alveolar lavage either at baseline or is anticipated to be too high a risk for lavage on Day 1 of the study
  • Intubation for cardiopulmonary arrest
  • Intubation for status asthmaticus, pulmonary embolus, or myocardia infarction
  • Anticipated survival less than 48 hours from intubation
  • Anticipated survival less than 28 days due to pre-existing medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233207


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104-2499
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Margaret Neff, MD University of Washington

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00233207     History of Changes
Other Study ID Numbers: 328
P50HL073996 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: December 2007

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries