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Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU

NCT ID: NCT00770978

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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 plasma. Pharmacokinetic parameters such as clearance and volume of distribution will be calculated. 1000mg every 8hours or every 12 hours

Conditions

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ICU

Keywords

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ICU

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceftobiprole q12h

Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Group Type EXPERIMENTAL

ceftobiprole q12h

Intervention Type DRUG

Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Ceftobiprole q8h

Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Group Type EXPERIMENTAL

ceftobiprole q8h

Intervention Type DRUG

Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Interventions

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ceftobiprole q12h

Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Intervention Type DRUG

ceftobiprole q8h

Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed Consent
* Between 18 and 75 years of age inclusive
* 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

* Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
* Renal impairment (CrCl \< 50 mL/min) or dialysis
* History of seizures
* ALT or AST \> 5 times upper normal limit
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Birmingham, Alabama, United States

Site Status

Chicago, Illinois, United States

Site Status

Beech Grove, Indiana, United States

Site Status

Omaha, Nebraska, United States

Site Status

Aalst, , Belgium

Site Status

Edegem, , Belgium

Site Status

Greenfield Park, Quebec, Canada

Site Status

Jerusalem, , Israel

Site Status

Gwangju, , South Korea

Site Status

Incheon, , South Korea

Site Status

Seoul, , South Korea

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Countries

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United States Belgium Canada Israel South Korea Spain

Other Identifiers

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NOS-1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR014911

Identifier Type: -

Identifier Source: org_study_id