Status:
TERMINATED
IC14 Antibodies to Treat Individuals With Acute Lung Injury
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome, Adult
Lung Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 i...
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 resu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00233207
Start Date
September 1 2005
End Date
June 1 2007
Last Update
May 16 2017
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98104-2499