IC14 Antibodies to Treat Individuals With Acute Lung Injury

Stopped early · Phase 2

Conditions studied: Respiratory Distress Syndrome, Adult, Lung Diseases

In brief

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).

Key facts

Study ID: NCT00233207
Run by: University of Washington
People needed: 13
Starts: 2005-09-01
Expected to finish: 2007-06-01
Last updated by the study team: 2017-05-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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