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

NCT00770978 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-07-30

No results posted yet for this study

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

Interventions

DRUG

ceftobiprole q12h

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

DRUG

ceftobiprole q8h

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

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States
  • Belgium
  • Canada
  • Israel
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00770978 on ClinicalTrials.gov