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Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Primary Purpose

Ventilator Associated Pneumonia

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Ceftobiprole

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia focused on measuring VAP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ceftobiprole

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Safety will be evaluated throughout the study.

Full Information

NCT ID

NCT00771719

First Posted

October 9, 2008

Last Updated

July 27, 2012

Sponsor

Basilea Pharmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT00771719

Brief Title

Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

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 Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

Study closed due to lack of enrollment; challenging patient population.

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Basilea Pharmaceutica

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator Associated Pneumonia

Keywords

VAP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ceftobiprole

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ceftobiprole

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Safety will be evaluated throughout the study.

Time Frame

Study Duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=792&filename=CR015304_CSR.pdf

Description

Open Label pharmacokinetic in Adult Patients with Ventilator-Associated Pneumonia

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Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

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