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

NCT00770978 | Completed Phase 1

• 2 other identifiers: CR014911NOS-1001
• Study Type: interventional
• Target: 33
• Locations: 6 countries
• Sites: 13

Brief Summary

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.

Conditions

ICU

Keywords

ICU

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose

  3 days

Secondary Outcomes (1)

• Safety will be evaluated throughout the study.

  7 days

Study Arms (2)

Ceftobiprole q12h

EXPERIMENTAL

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

Drug: ceftobiprole q12h

Ceftobiprole q8h

EXPERIMENTAL

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

Drug: ceftobiprole q8h

Interventions

ceftobiprole q12h DRUG

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

Ceftobiprole q12h

ceftobiprole q8h DRUG

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

Ceftobiprole q8h

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Study Sites (13)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Beech Grove, Indiana, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Edegem, Belgium

Location

Unknown Facility

Greenfield Park, Quebec, Canada

Location

Unknown Facility

Jerusalem, Israel

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

KR (3); ES (2); IL (1); US (4); CA (1); BE (2)