Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Sponsor

Basilea Pharmaceutica (Industry)

Overall Status

Terminated

CT.gov ID

NCT00771719

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

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 :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 [2 days]

Secondary Outcome Measures

Safety will be evaluated throughout the study. [Study Duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

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.