Open Label Pharmacokinetic Study in Adult Patients With Ventilator-Associated Pneumonia

This study is currently recruiting participants.

Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., October 2008

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00771719

Purpose

The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and the tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Condition	Intervention	Phase
Ventilator Associated Pneumonia	Drug: ceftobiprole	Phase I

MedlinePlus related topics: Pneumonia Urine and Urination

Drug Information available for: Ceftobiprole medocaril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho Alveolar Penetration in Adults With Ventilator-Associated Pneumonia

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Pharmacokinetics (to measure the levels of ceftobiprole in the blood, urine and the tissues of the lungs) during dosing and 24 hours after the last dose. infused

Secondary Outcome Measures:

Safety will be evaluated throughout the study.

Estimated Enrollment:	22
Study Start Date:	August 2008

Detailed Description:

Patients will receive an 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 doses administered intravenously every 8 hours.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771719

Locations

Korea, Republic of
Korea University Anam Hospital	Recruiting
Seoul, Korea, Republic of, 136-705
Contact: MIN-JA KIM 02-920-5677

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Study ID Numbers:	CR015304
Study First Received:	October 9, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00771719
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Ventilator Associated Pneumonia
VAP
ceftobiprole

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009