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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	ALTANA Pharma
Information provided by:	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

MedlinePlus related topics:

Pneumonia

Drug Information available for:

Venticute

U.S. FDA Resources

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

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

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
Estimated 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

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	BY2001/M1-007
First Received:	December 23, 2003
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00074906
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Aspiration of gastric contents

Study placed in the following topic categories:

Signs and Symptoms

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Signs and Symptoms, Respiratory

Respiratory Aspiration

Pneumonia

ClinicalTrials.gov processed this record on November 30, 2008