Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia
NCT ID: NCT00771719
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2008-10-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ceftobiprole
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
Ceftobiprole
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
Interventions
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Ceftobiprole
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 75 years of age inclusive
* VAP - 48 hours after onset of mechanical ventilation
* BMI 18 - 35 inclusive
* Albumin \< 3.3 g/dL or clinical evidence of edema
* Negative Pregnancy test
* Expected survival of at least 7 days
Exclusion Criteria
* Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
* History of seizures
* Sustained shock, unresponsive to sympathomimetics
* Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)
18 Years
75 Years
ALL
No
Sponsors
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Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Countries
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Related Links
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Open Label pharmacokinetic in Adult Patients with Ventilator-Associated Pneumonia
Other Identifiers
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NOS-1002
Identifier Type: OTHER
Identifier Source: secondary_id
CR015304
Identifier Type: -
Identifier Source: org_study_id