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Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280514
First Posted: January 23, 2006
Last Update Posted: August 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose
Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested. Patients with an abscess scheduled for drainage will receive study drugs (single or multiple dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be determined using a pharmacokinetic model.

Condition Intervention Phase
Abscess Cysts Drug: cefpirome and moxifloxacin administration Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Official Title: Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • AUC
  • AUC0-12/24h
  • Cmax
  • Tmax
  • t1/2ß
  • Cav(ss)

Secondary Outcome Measures:
  • ratios of AUC and Cav(ss) to MIC
  • T>MIC

Estimated Enrollment: 20
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male, aged between 18 and 90 years.
  • Written informed consent.
  • Abscess formation or abdominal cyst scheduled to drainage.
  • Plasma creatinine <1.5 mg/dL

Exclusion Criteria:

  • Pregnancy or lactation.
  • Hemodialysis or hemofiltration
  • Allergy or hypersensitivity against study drugs
  • Massive edemata or hypernatremia
  • Reduced liver function (Child-Pugh A, B, C)
  • Relevant prolongation of QT-interval
  • CNS-diseases which predispose for cramps
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00280514


Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Johannes Pleiner, MD Medical University of Vienna, Dep. of Clinical Pharmacology
  More Information

Publications:
Responsible Party: Markus Müller, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00280514     History of Changes
Other Study ID Numbers: abscess-cef-moxi
EUdraCT no. 2005-004455-35
First Submitted: January 20, 2006
First Posted: January 23, 2006
Last Update Posted: August 4, 2010
Last Verified: November 2005

Keywords provided by Medical University of Vienna:
abscess
penetration
antibiotics
cefpirome
moxifloxacin
abdominal cyst

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Moxifloxacin
Fluoroquinolones
Cefpirome
Cephalosporins
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors