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Calfactant for Direct Acute Respiratory Distress Syndrome

NCT00682500 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2012-07-24

No results posted yet for this study

Summary

This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

DRUG

Calfactant

Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.

DRUG

Room Air (placebo)

Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met

Sponsors & Collaborators

  • Pneuma Pharmaceuticals Incorporated

    lead OTHER

Principal Investigators

  • Douglas Willson, MD · Univeristy of Virginia Health Sciences Center

  • Jonathon Truwit, MD · University of Virginia Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • New Zealand
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682500 on ClinicalTrials.gov