Status:
TERMINATED
Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Ventilator Associated Pneumonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the dr...
Detailed Description
Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lava...
Eligibility Criteria
Inclusion
- Informed Consent
- 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
- Renal impairment (CrCl \< 80 mL/min)
- 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00771719
Start Date
October 1 2008
End Date
November 1 2009
Last Update
July 30 2012
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