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

ICU Clinical Trial

Official title:

Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770978
• Other study ID #: CR014911
• Secondary ID: NOS-1001
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2008
• Last updated: July 27, 2012
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2012
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ICU

Intervention

Drug:
• ceftobiprole q12h
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Israel,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose		3 days	No
Secondary	Safety will be evaluated throughout the study.		7 days	Yes