Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU
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ClinicalTrials.gov Identifier: NCT00770978 |
Recruitment Status :
Completed
First Posted : October 10, 2008
Last Update Posted : July 30, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ICU | Drug: ceftobiprole q12h Drug: ceftobiprole q8h | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Ceftobiprole q12h
Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
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Drug: ceftobiprole q12h
Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 |
Experimental: Ceftobiprole q8h
Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
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Drug: ceftobiprole q8h
Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 |
- Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose [ Time Frame: 3 days ]
- Safety will be evaluated throughout the study. [ Time Frame: 7 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770978
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Indiana | |
Beech Grove, Indiana, United States | |
United States, Nebraska | |
Omaha, Nebraska, United States | |
Belgium | |
Aalst, Belgium | |
Edegem, Belgium | |
Canada, Quebec | |
Greenfield Park N/A, Quebec, Canada | |
Israel | |
Jerusalem, Israel | |
Korea, Republic of | |
Gwangju, Korea, Republic of | |
Incheon, Korea, Republic of | |
Seoul, Korea, Republic of | |
Spain | |
Barcelona, Spain | |
Madrid, Spain |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Basilea Pharmaceutica |
ClinicalTrials.gov Identifier: | NCT00770978 |
Other Study ID Numbers: |
CR014911 NOS-1001 ( Other Identifier: Basilea Internal Reference ) |
First Posted: | October 10, 2008 Key Record Dates |
Last Update Posted: | July 30, 2012 |
Last Verified: | July 2012 |
ICU |
Ceftobiprole Ceftobiprole medocaril Cephalosporins Anti-Bacterial Agents Anti-Infective Agents |