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

Takeda

Status and phase

Completed

Phase 3

Conditions

Pneumonia

Treatments

Drug: Venticute

Study type

Interventional

Funder types

Industry

Identifiers

NCT00074906

BY2001/M1-007

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

12 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.