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

Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis (CASPHYLAX)
This study is currently recruiting participants.
Verified July 2011 by Wuerzburg University Hospital

First Received on March 17, 2011.  
Last Updated on July 28, 2011  
History of Changes
Sponsor: Wuerzburg University Hospital
Collaborator: Merck
Information provided by: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01318148
  Purpose

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 Intervention Phase
Fungal Infection Drug: caspofungin Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:

  • caspofungin pharmacokinetic [ Time Frame: day 20 (average), till end of enutropenia ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 20 (average), at end of neutropenia ] [ Designated as safety issue: No ]
    caspofungin serum concentrations

  • Incidence of invasive fungal disease and outcome [ Time Frame: day 100 after start of chemotherapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 34 (average), 2 weeks after end of neutropenia ] [ Designated as safety issue: Yes ]
    Caspofungin related and all adverse and serious adverse events

Estimated Enrollment: 25
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: Caspofungin Drug: caspofungin

Intermittent intravenous application of caspofungin
Other Name: Cancidas

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 EORTC/MSG criteria, revised 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318148

Contacts
Contact: Werner J Heinz, MD +49 931 201-0 ext 40044 Heinz_w@klinik.uni-wuerzburg.de
Contact: Anna Kuhn +49 931 201-0 ext 40158 Kuhn_A3@klinik.uni-wuerzburg.de

Locations
Germany
University of Wuerzburg Medical Centre, Department of Internal Medicine II Recruiting
Wuerzburg, Germany, 97080
Contact: Werner J Heinz, MD     +49 931 201 -0 ext 40044     Heinz_w@klinik.uni-wuerzburg.de    
Contact: Anna Kuhn     +49 931 201 -0 ext 40158     Kuhn_A3@klinik.uni-wuerzburg.de    
Principal Investigator: Werner J Heinz, MD            
Sponsors and Collaborators
Wuerzburg University Hospital
Merck
Investigators
Study Chair: Werner J Heinz, MD University of Wuerzburg Medical Centre, Department of Internal Medicine II
  More Information

No publications provided

Responsible Party: Medical Director, University of Würzburg Medical Centre
ClinicalTrials.gov Identifier: NCT01318148    
History of Changes
Other Study ID Numbers: UKW-Inf-001, 2009-015159-26
Study First Received: March 17, 2011
Last Updated: July 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wuerzburg University Hospital:

Echinocandins
Caspofungin
Pharmacokinetics
Prophylaxis
Antifungal
Aspergillosis
Acute Leucemia

Additional relevant MeSH terms:

Mycoses
Antifungal Agents
Clotrimazole
Miconazole
Caspofungin
Echinocandins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2012

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