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

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.
ClinicalTrials.gov Identifier: NCT00280514
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : August 4, 2010
Information provided by:
Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment Phase
Abscess Cysts Drug: cefpirome and moxifloxacin administration Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Official Title: Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration
Study Start Date : January 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Primary Outcome Measures :
  1. AUC
  2. AUC0-12/24h
  3. Cmax
  4. Tmax
  5. t1/2ß
  6. Cav(ss)

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

Information from the National Library of Medicine

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

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

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

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Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Johannes Pleiner, MD Medical University of Vienna, Dep. of Clinical Pharmacology
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Responsible Party: Markus Müller, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00280514    
Other Study ID Numbers: abscess-cef-moxi
EUdraCT no. 2005-004455-35
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: August 4, 2010
Last Verified: November 2005
Keywords provided by Medical University of Vienna:
abdominal cyst
Additional relevant MeSH terms:
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Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents