NCT00233207

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).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 16, 2017

Status Verified

December 1, 2007

First QC Date

October 3, 2005

Last Update Submit

May 12, 2017

Conditions

Respiratory Distress Syndrome, AdultLung Diseases

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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)

Interventions

IC14DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of ALI, defined as the following:
  • Acute onset (less than 28 days from study entry)
  • PaO2/FiO2 of less than 300
  • Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
  • Requirement for positive pressure ventilation via endotracheal tube
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104-2499, United States

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration Disorders

Study Officials

  • Margaret Neff, MD

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

September 1, 2005

Study Completion

June 1, 2007

Last Updated

May 16, 2017

Record last verified: 2007-12

Locations

US(1)