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Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis — CASPHYLAX  

Fungal Infection Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01318148
Study type Interventional
Source Wuerzburg University Hospital
Contact
Status Completed
Phase Phase 2
Start date April 2011
Completion date October 2013
View Details
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