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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015159-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.
Pharmacokinetic and safety of caspofungin, in an intermittent dosing schedule, for prophylaxis of invasive fungal (IFI) infections will be evaluated in patients receiving induction chemotherapy for treatment of acute myeloid leukemia, myelodysplastic syndrome with blast crisis or acute lymphatic leukemia.
For prophylaxis caspofungin once daily will be given three times a week after a loading phase of three days. For drug monitoring serum samples will be collected from the first day of trial medication till one day after end of therapy (EOT). Invasive fungal infections will be diagnosed analog the criteria defined by the European organization for Research and Treatment of Cancer and the Mycosis Study Group (EORTC/MSG), revised in 2008.
Caspofungin prophylaxis will be stopped after the end of neutropenia, in case of documented proven or probable invasive fungal disease and in case of a serious adverse event attributable to the study drug, for which in view of the investigator further usage of the study drug should be avoided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caspofungin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin | Drug | Intermittent intravenous application of caspofungin |
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| Measure | Description | Time Frame |
|---|---|---|
| caspofungin pharmacokinetic | To characterize the pharmacokinetic of caspofungin IV solution in an intermittent dosing schedule of 3 times a week after a 3 days loading in a representative subject population. | day 20 (average), till end of enutropenia |
| Measure | Description | Time Frame |
|---|---|---|
| Caspofungin pharmacokinetic | caspofungin serum concentrations | day 20 (average), at end of neutropenia |
| Incidence of invasive fungal disease and outcome | Incidence of proven or probable invasive fungal disease according to the revised EORTC/MSG criteria during the period of prophylaxis and during follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner J Heinz, MD | University of Wuerzburg Medical Centre, Department of Internal Medicine II | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wuerzburg Medical Centre, Department of Internal Medicine II | Würzburg | 97080 | Germany |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| day 100 after start of chemotherapy |
| Safety of intermittent caspofungin | Caspofungin related and all adverse and serious adverse events | day 34 (average), 2 weeks after end of neutropenia |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |