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

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ClinicalTrials.gov Identifier: NCT01318148
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Werner J. Heinz, Wuerzburg University Hospital

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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 : April 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Caspofungin Drug: caspofungin
Intermittent intravenous application of caspofungin
Other Name: Cancidas



Primary Outcome Measures :
  1. caspofungin pharmacokinetic [ Time Frame: 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 :
  1. Caspofungin pharmacokinetic [ Time Frame: day 20 (average), at end of neutropenia ]
    caspofungin serum concentrations

  2. Incidence of invasive fungal disease and outcome [ Time Frame: 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.

  3. Safety of intermittent caspofungin [ Time Frame: day 34 (average), 2 weeks after end of neutropenia ]
    Caspofungin related and all adverse and serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318148


Locations
Germany
University of Wuerzburg Medical Centre, Department of Internal Medicine II
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Werner J. Heinz
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Werner J Heinz, MD University of Wuerzburg Medical Centre, Department of Internal Medicine II

Responsible Party: Werner J. Heinz, Consultant Infectious Diseases, Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01318148     History of Changes
Other Study ID Numbers: UKW-Inf-001
2009-015159-26 ( EudraCT Number )
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Werner J. Heinz, Wuerzburg University Hospital:
Echinocandins
Caspofungin
Pharmacokinetics
Prophylaxis
Antifungal
Aspergillosis
Acute Leucemia

Additional relevant MeSH terms:
Mycoses
Antifungal Agents
Miconazole
Caspofungin
Echinocandins
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors