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OpenTrials
Completed

NCT Number: NCT00770978

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

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.

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Key information

Conditions

ICU

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aalst, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 q8h

Drug

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

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. Safety will be evaluated throughout the study.

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 10, 2008
Registry last updated
Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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