Plasma and abscess fluid pharmacokinetics of cefpirome and moxifloxacin after single dose and multiple dose administration - Abscess-Cef-Moxi

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004455-35-AT

Enrollment

Registered

2005-10-18

Start date

2005-11-22

Completion date

Unknown

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess or abdominal cyst

Interventions

Trade Name: Cefrom Product Name: Cefrom Pharmaceutical Form: Intravenous infusion Trade Name: Avelox Product Name: Avelox Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to measure concentrations of cefpirome and moxifloxacin in abscess fluid and abdominal cysts; describe the concentration time-curve of these agents in pus; Individual pharmacokinetic parameters will be determined for abscess (cyst) fluid after a single dose and at steady state: AUC, AUC0-12/24h, Cmax, Tmax, t1/2ß, Cav(ss); define the therapeutic potential of cefpirome and moxifloxacin in the treatment of severe bacterial infections going ahead with abscess formation and infected abdominal cysts. ;Secondary Objective: Plasma (single dose and steady state): AUC, AUC0-12/24h, Cmax, Tmax, t1/2ß, AUC0-12/24h; Pus and plasma: ratios of AUC and Cav(ss) to MIC, T>MIC. The following parameters will also be determined if possible: the diameter of the pericapsular space with enrichment of contrast agent, the degree of contrast agent enhancement in this zone and the pus density, rate of drug degradation in pus at body temperature in vitro, pH-value of pus, pus viscosity and specific weight. ;Primary end point(s): The cefpirome and moxifloxacin concentrations in abscess fluid will be measured (Ci). Considering plasma PK and the ratio of the surface to volume ratio of the abscess, the individual concentration versus time-curve in abscess fluid will be calculated. Individual pharmacokinetic parameters will be determined for abscess (cyst) fluid after a single dose and at steady state: AUC, AUC0-12/24h, Cmax, Tmax, t1/2ß, Cav(ss).	—

Measure

Time frame

Main Objective: to measure concentrations of cefpirome and moxifloxacin in abscess fluid and abdominal cysts; describe the concentration time-curve of these agents in pus; Individual pharmacokinetic parameters will be determined for abscess (cyst) fluid after a single dose and at steady state: AUC, AUC0-12/24h, Cmax, Tmax, t1/2ß, Cav(ss); define the therapeutic potential of cefpirome and moxifloxacin in the treatment of severe bacterial infections going ahead with abscess formation and infected abdominal cysts. ;Secondary Objective: Plasma (single dose and steady state): AUC, AUC0-12/24h, Cmax, Tmax, t1/2ß, AUC0-12/24h; Pus and plasma: ratios of AUC and Cav(ss) to MIC, T>MIC. The following parameters will also be determined if possible: the diameter of the pericapsular space with enrichment of contrast agent, the degree of contrast agent enhancement in this zone and the pus density, rate of drug degradation in pus at body temperature in vitro, pH-value of pus, pus viscosity and specific weight. ;Primary end point(s): The cefpirome and moxifloxacin concentrations in abscess fluid will be measured (Ci). Considering plasma PK and the ratio of the surface to volume ratio of the abscess, the individual concentration versus time-curve in abscess fluid will be calculated. Individual pharmacokinetic parameters will be determined for abscess (cyst) fluid after a single dose and at steady state: AUC, AUC0-12/24h, Cmax, Tmax, t1/2ß, Cav(ss).

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026