IC14 Antibodies to Treat Individuals With Acute Lung Injury

This study has been terminated.
(Unable to meet enrollment number to complete study, study stopped June 30, 2007)
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00233207
First received: October 3, 2005
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Respiratory Distress Syndrome, Adult
Lung Diseases
Drug: IC14
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Acute Lung Injury Clinical Trials Incubator Unit

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Secondary Outcome Measures:
  • 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)

Enrollment: 13
Study Start Date: September 2005
Study Completion Date: June 2007
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233207

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104-2499
Sponsors and Collaborators
Investigators
Study Chair: Margaret Neff, MD University of Washington
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233207     History of Changes
Other Study ID Numbers: 328, P50 HL073996
Study First Received: October 3, 2005
Last Updated: December 13, 2007
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 20, 2014