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

Sponsor

Werner J. Heinz (Other)

Overall Status

Completed

CT.gov ID

NCT01318148

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fungal Infection	Drug: caspofungin	Phase 2

Detailed 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

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 :

Apr 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Caspofungin	Drug: caspofungin Intermittent intravenous application of caspofungin Other Names: Cancidas

Arm

Intervention/Treatment

Experimental: Caspofungin

Drug: caspofungin

Intermittent intravenous application of caspofungin

Other Names:

Cancidas

Outcome Measures

Primary Outcome Measures

caspofungin pharmacokinetic [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.

Secondary Outcome Measures

Caspofungin pharmacokinetic [day 20 (average), at end of neutropenia]
caspofungin serum concentrations
Incidence of invasive fungal disease and outcome [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 [day 34 (average), 2 weeks after end of neutropenia]
Caspofungin related and all adverse and serious adverse events