Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771719
• Other study ID #: CR015304
• Secondary ID: NOS-1002
• Status: Terminated
• Phase: Phase 1
• First received: October 9, 2008
• Last updated: July 27, 2012
• Start date: October 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2012
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety will be evaluated throughout the study.		Study Duration	Yes

External Links

•   Open Label pharmacokinetic in Adult Patients with Ventilator-Associated Pneumonia