Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)

This study has been completed.

First Received on December 23, 2003. Last Updated on January 18, 2012 History of Changes

Sponsor:	ALTANA Pharma
Information provided by (Responsible Party):	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00074906

Purpose

Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.

Condition	Intervention	Phase
Pneumonia	Drug: Venticute	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Venticute in Patients With Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A Randomized, Multinational, Multicenter, Parallel Group, Double Blind, Control Group Study

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Venticute

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

Survival on day 28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

How long the lung and the patient (overall) are recovering [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1200
Study Start Date:	November 2003
Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment

Eligibility

Ages Eligible for Study:	12 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main inclusion criteria:

Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia

Main exclusion criteria:

Principal source of infection or sepsis is outside the lung
Severe pre-existing lung disease
Cancer metastatic to the lung or any end stage malignancy
History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation
Patient is morbidly obese
Patient has a diagnosis of acute necrotizing pancreatitis

Additional criteria may apply and examination by an investigator is required to determine eligibility.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074906

Show 92 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:	Roger G. Spragg, MD	University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA
Principal Investigator:	Werner Seeger, MD	Justus-Liebig-Universität, Gießen, Germany
Principal Investigator:	Andreas Günther, MD	University of Giessen

More Information

No publications provided by ALTANA Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Spragg RG, Taut FJ, Lewis JF, Schenk P, Ruppert C, Dean N, Krell K, Karabinis A, Günther A. Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1055-61. Epub 2010 Dec 10.

Responsible Party:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00074906 History of Changes
Other Study ID Numbers:	BY2001/M1-007
Study First Received:	December 23, 2003
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Aspiration of gastric contents

Additional relevant MeSH terms:

Respiratory Aspiration
Pneumonia
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 12, 2012