Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT00074906
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2003-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
Sponsor:
Organization:
Raw JSON
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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. doi: 10.1164/rccm.201009-1424OC. Epub 2010 Dec 10.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria:\n\n* Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia\n\nMain exclusion criteria:\n\n* Principal source of infection or sepsis is outside the lung\n* Severe pre-existing lung disease\n* Cancer metastatic to the lung or any end stage malignancy\n* History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation\n* Patient is morbidly obese\n* Patient has a diagnosis of acute necrotizing pancreatitis\n\nAdditional criteria may apply and examination by an investigator is required to determine eligibility.'}, 'identificationModule': {'nctId': 'NCT00074906', 'briefTitle': 'Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BY2001/M1-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Venticute', 'type': 'DRUG', 'description': 'Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide SA', 'country': 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Kingdom', 'facility': 'Altana Pharma/Nycomed'}], 'overallOfficials': [{'name': 'Roger G. 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