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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001902-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.
After given informed consent, patients scheduled for planned liver resection are enrolled into the study. The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. Blood and healthy liver tissue are sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a two-compartment model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Experimental | Moxifloxacin 400 mg i.v. |
|
| No drug | No Intervention | 2 Patients were included as controls- no MXF given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin 400 mg | Drug | The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration (mg/L) of moxifloxacin in liver tissue | The first outcome of this study was to analyze the concentration of MFX in liver tissue of patients who received MFX 400 mg i.v.. | 1.5 hours after moxifloxacin infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (mg/L) of moxifloxacin in serum | The maximum concentration (mg/L) of moxifloxacin in the serum of patients who received 400 mg moxifloxacin was measured at the end of the intravenous infusion. | at the end of intravenous infusion |
| Number of participants with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin K Schilling, MD | University hospital of the Saarland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of the Saarland | Homburg/Saar | 66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16904875 | Background | Weinrich M, Scheingraber S, Stremovskaia T, Schilling MK, Kees F, Pistorius GA. Liver tissue concentrations of levofloxacin after single intravenous administration of 500 mg for antibiotic prophylaxis in liver surgery. Int J Antimicrob Agents. 2006 Sep;28(3):221-5. doi: 10.1016/j.ijantimicag.2006.04.012. Epub 2006 Aug 14. | |
| 22526014 |
| Label | URL |
|---|---|
| PI´s institute homepage | View source |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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The number of participants and kind of adverse events were recorded up to 48 hours after intravenous infusion of 400 mg moxifloxacin. |
| 48 hours |
| Area under the plasma concentration versus time curve (AUC) of moxifloxacin (mg*h/L) | The serum concentration of moxifloxacin was measured at different time points (2, 3, 4, 6, 8, 12, 24, 36 hour after infusion) up to 48 hours after intravenous infusion of 400 mg moxifloxacin. | 48 hours |
| Justinger C, Schilling MK, Kees MG, Kauffels A, Hirschmann K, Kopp B, Kees F, Kollmar O. Penetration of moxifloxacin into liver tissue. Int J Antimicrob Agents. 2012 Jun;39(6):505-9. doi: 10.1016/j.ijantimicag.2012.01.022. Epub 2012 Apr 21. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |