Open Label Pharmacokinetic in Adult Patients With Ventila... | NCT00771719

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

NCT00771719

Sponsor

Basilea Pharmaceutica

Status

Terminated

Last Update Posted

Jul 30, 2012Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Ventilator Associated Pneumonia

Interventions

Ceftobiprole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NOS-1002	Other Identifier	Basilea (Internal Reference)

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Oct 9, 2008

First Submission Date that Met QC Criteria

Oct 9, 2008

First Posted Date

Oct 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2012

Last Update Posted Date

Jul 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ceftobiprole	Experimental	Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days	Drug: Ceftobiprole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftobiprole	Drug	Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days	Ceftobiprole

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia