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

Tracking Information

First Received Date ^ICMJE

December 23, 2003

Last Updated Date

December 12, 2008

Start Date ^ICMJE

November 2003

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Survival on day 28

Change History

Complete list of historical versions of study NCT00074906 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

How quickly the lung and the patient overall are recovering.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pneumonia

Intervention ^ICMJE

Drug: Venticute

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1200

Completion Date

June 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Austria, Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Israel, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00074906

Responsible Party

Nycomed, Nycomed

Study ID Numbers ^ICMJE

BY2001/M1-007

Study Sponsor ^ICMJE

ALTANA Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

ALTANA Pharma

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP