Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis (CASPHYLAX)
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|ClinicalTrials.gov Identifier: NCT01318148|
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : January 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Fungal Infection||Drug: caspofungin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
Intermittent intravenous application of caspofungin
Other Name: Cancidas
- caspofungin pharmacokinetic [ Time Frame: day 20 (average), till end of enutropenia ]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.
- Caspofungin pharmacokinetic [ Time Frame: day 20 (average), at end of neutropenia ]caspofungin serum concentrations
- Incidence of invasive fungal disease and outcome [ Time Frame: day 100 after start of chemotherapy ]Incidence of proven or probable invasive fungal disease according to the revised EORTC/MSG criteria during the period of prophylaxis and during follow up.
- Safety of intermittent caspofungin [ Time Frame: day 34 (average), 2 weeks after end of neutropenia ]Caspofungin related and all adverse and serious adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318148
|University of Wuerzburg Medical Centre, Department of Internal Medicine II|
|Wuerzburg, Germany, 97080|
|Study Chair:||Werner J Heinz, MD||University of Wuerzburg Medical Centre, Department of Internal Medicine II|