NCT00280514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 4, 2010

Status Verified

November 1, 2005

Enrollment Period

3.9 years

First QC Date

January 20, 2006

Last Update Submit

August 3, 2010

Conditions

AbscessCysts

Keywords

abscesspenetrationantibioticscefpiromemoxifloxacinabdominal cyst

Outcome Measures

Primary Outcomes (6)

  • AUC

  • AUC0-12/24h

  • Cmax

  • Tmax

  • t1/2ß

  • Cav(ss)

Secondary Outcomes (2)

  • ratios of AUC and Cav(ss) to MIC

  • T>MIC

Interventions

cefpirome and moxifloxacin administrationDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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. doi: 10.1128/AAC.49.11.4448-4454.2005.

    PMID: 16251282BACKGROUND

MeSH Terms

Conditions

AbscessCysts

Interventions

Cefpirome

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasmsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Johannes Pleiner, MD

    Medical University of Vienna, Dep. of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 4, 2010

Record last verified: 2005-11

Locations

AU(1)