Abscess Clinical Trial
Official title:
Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC | |||
Primary | AUC0-12/24h | |||
Primary | Cmax | |||
Primary | Tmax | |||
Primary | t1/2ß | |||
Primary | Cav(ss) | |||
Secondary | ratios of AUC and Cav(ss) to MIC | |||
Secondary | T>MIC |
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