Lung Diseases Clinical Trial
Official title:
Acute Lung Injury Clinical Trials Incubator Unit
Verified date | December 2007 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 13 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8) | |||
Secondary | Worst Murray Lung Injury Score | |||
Secondary | Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28) | |||
Secondary | Infections-nosocomial and/or surgical site infections | |||
Secondary | Ventilator-free days | |||
Secondary | Mortality (measured at Day 28) |
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