IC14 Antibodies to Treat Individuals With Acute Lung Injury
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 results of antibody interaction with CD14 suggest that CD14 has a central role in the recognition of bacterial products and the induction of innate immune responses. Although beneficial, when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful. This study will implement strategies to block CD14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response, mechanical ventilation days, multiple organ failure, and severity of organ dysfunction in patients with sepsis-induced ALI.
DESIGN NARRATIVE:
The primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at Days 2 and 3, and Days 6 to 8.
The key secondary outcomes of this study will be: 1) Worst Murray Lung Injury Score (measured at Days 1 through 7, and Day 28); 2) Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28); 3) Infections-nosocomial and/or surgical site infections (measured at Day 28); 4) Ventilator-free days (measured at Day 28); and 5) Mortality (measured at Day 28).
Study Design
Outcome Measures
Primary Outcome Measures
- Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8) []
Secondary Outcome Measures
- 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) []
Eligibility Criteria
Criteria
Inclusion Criteria:
- Presence of ALI, defined as the following:
-
Acute onset (less than 28 days from study entry)
-
PaO2/FiO2 of less than 300
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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
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No clinical evidence of left atrial hypertension
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Clinical indication for antimicrobial therapy at the time of randomization
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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
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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
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Intubation for cardiopulmonary arrest
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Intubation for status asthmaticus, pulmonary embolus, or myocardia infarction
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Anticipated survival less than 48 hours from intubation
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Anticipated survival less than 28 days due to pre-existing medical condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Washington | Seattle | Washington | United States | 98104-2499 |
Sponsors and Collaborators
- University of Washington
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Study Chair: Margaret Neff, MD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 328
- P50HL073996