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

This study has been completed.

First Received on January 20, 2006. Last Updated on August 3, 2010 History of Changes

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00280514

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 IV

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

Resource links provided by NLM:

Drug Information available for: Cefpirome Cefpirome sulfate Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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)

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Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Sauermann R, Karch R, Langenberger H, Kettenbach J, Mayer-Helm B, Petsch M, Wagner C, Sautner T, Gattringer R, Karanikas G, Joukhadar C. Antibiotic abscess penetration: fosfomycin levels measured in pus and simulated concentration-time profiles. Antimicrob Agents Chemother. 2005 Nov;49(11):4448-54.

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
Study First Received:	January 20, 2006
Last Updated:	August 3, 2010
Health Authority:	Austria: "Bundesministerium für Gesundheit und Frauen"

Keywords provided by Medical University of Vienna:

abscess
penetration
antibiotics

cefpirome
moxifloxacin
abdominal cyst

Additional relevant MeSH terms:

Abscess
Cysts
Suppuration
Infection
Inflammation
Pathologic Processes
Neoplasms
Pathological Conditions, Anatomical
Cefpirome
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012