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

Information source: Wuerzburg University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fungal Infection

Intervention: caspofungin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Werner J. Heinz

Official(s) and/or principal investigator(s):
Werner J Heinz, MD, Study Chair, Affiliation: University of Wuerzburg Medical Centre, Department of Internal Medicine II


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 Details

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

Primary outcome: caspofungin pharmacokinetic

Secondary outcome:

Caspofungin pharmacokinetic

Incidence of invasive fungal disease and outcome

Safety of intermittent caspofungin

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

University of Wuerzburg Medical Centre, Department of Internal Medicine II, Wuerzburg 97080, Germany
Additional Information

Starting date: April 2011
Last updated: January 8, 2014

Page last updated: August 23, 2015

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