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

Werner J. Heinz

Status and phase: Completed; Phase 2

Conditions: Fungal Infection

Treatments: Drug: caspofungin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01318148

UKW-Inf-001

2009-015159-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia
• receiving induction chemotherapy

Exclusion criteria

• current or need of systemic antifungal therapy
• history of proven or probable invasive aspergillus infection
• pregnant or breastfeeding women
• weight more than 100 kg
• history of allergy, hypersensitivity or any serious reaction to caspofungin

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Caspofungin

Experimental group

Treatment:

Drug: caspofungin