Completed

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

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What is being tested

Venticute

Drug
Who is being recruted

Infections+2

+ Lung Diseases

+ Respiratory Tract Diseases

From 12 to 85 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorTakeda
Last updated: May 7, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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.

NCT00074906
Principal SponsorTakeda
Last updated: May 7, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsPneumonia

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 92 locations

Altana Pharma/Nycomed

Adelaide SA, AustraliaOpen Altana Pharma/Nycomed in Google Maps

Altana Pharma/Nycomed

Bedford Park, Adelaide S, Australia

Altana Pharma/Nycomed

Clayton, VIC, Australia

Altana Pharma/Nycomed

Fremantle, WA, Australia
Completed92 Study Centers