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Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

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ClinicalTrials.gov Identifier: NCT00771719
Recruitment Status : Terminated (Study closed due to lack of enrollment; challenging patient population.)
First Posted : October 13, 2008
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

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 drug will also be evaluated.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Drug: Ceftobiprole Phase 1

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 lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia
Study Start Date : October 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ceftobiprole
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
Drug: Ceftobiprole
Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days



Primary Outcome Measures :
  1. Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Safety will be evaluated throughout the study. [ Time Frame: Study Duration ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771719


Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00771719     History of Changes
Other Study ID Numbers: CR015304
NOS-1002 ( Other Identifier: Basilea (Internal Reference) )
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by Basilea Pharmaceutica:
VAP

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Ceftobiprole
Ceftobiprole medocaril
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents