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