Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771719

Enrollment

Registered

2008-10-13

Start date

2008-10-31

Completion date

2009-11-30

Last updated

2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

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.

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

Interventions

DRUGCeftobiprole

Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety will be evaluated throughout the study.	Study Duration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026