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

This study is currently recruiting participants.

Verified by Medical University of Vienna, November 2005

Sponsored by:	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 HPLC. Pharmacokinectics of the study drugs in pus and plasma will be determined using a pharmacokinetic model.

Condition	Intervention	Phase
Abscess or Abdominal Cyst	Drug: cefpirome and moxifloxacin administration	Phase IV

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Cefpirome Cefpirome sulfate

U.S. FDA Resources

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

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

Show Detailed Description

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

Contacts

Contact: Christian Joukhadar, MD	00431404002981	christian.joukhadar@meduniwien.ac.at
Contact: Robert Sauermann, MD	00431404002981	robert.sauermann@meduniwien.ac.at

Locations

Austria
Medical University Vienna	Recruiting
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Christian Joukhadar, 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.

Study ID Numbers:	abscess-cef-moxi, EUdraCT no. 2005-004455-35
Study First Received:	January 20, 2006
Last Updated:	January 20, 2006
ClinicalTrials.gov Identifier:	NCT00280514
Health Authority:	Austria: "Bundesministerium für Gesundheit und Frauen"

Keywords provided by Medical University of Vienna:

abscesss
penetration
antibiotics
cefpirome
moxifloxacin

Study placed in the following topic categories:

Cefpirome
Moxifloxacin
Abscess

Suppuration
Cysts
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009