IC14 Antibodies to Treat Individuals With Acute Lung Injury

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI); University of Washington
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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