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

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
caspofungin
Sponsored by
Werner J. Heinz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fungal Infection focused on measuring Echinocandins, Caspofungin, Pharmacokinetics, Prophylaxis, Antifungal, Aspergillosis, Acute Leucemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Wuerzburg Medical Centre, Department of Internal Medicine II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caspofungin

Arm Description

Outcomes

Primary Outcome Measures

caspofungin pharmacokinetic
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
caspofungin serum concentrations
Incidence of invasive fungal disease and outcome
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
Caspofungin related and all adverse and serious adverse events

Full Information

First Posted
March 17, 2011
Last Updated
January 8, 2014
Sponsor
Werner J. Heinz
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01318148
Brief Title
Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis
Acronym
CASPHYLAX
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Werner J. Heinz
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
Keywords
Echinocandins, Caspofungin, Pharmacokinetics, Prophylaxis, Antifungal, Aspergillosis, Acute Leucemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caspofungin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
caspofungin
Other Intervention Name(s)
Cancidas
Intervention Description
Intermittent intravenous application of caspofungin
Primary Outcome Measure Information:
Title
caspofungin pharmacokinetic
Description
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.
Time Frame
day 20 (average), till end of enutropenia
Secondary Outcome Measure Information:
Title
Caspofungin pharmacokinetic
Description
caspofungin serum concentrations
Time Frame
day 20 (average), at end of neutropenia
Title
Incidence of invasive fungal disease and outcome
Description
Incidence of proven or probable invasive fungal disease according to the revised EORTC/MSG criteria during the period of prophylaxis and during follow up.
Time Frame
day 100 after start of chemotherapy
Title
Safety of intermittent caspofungin
Description
Caspofungin related and all adverse and serious adverse events
Time Frame
day 34 (average), 2 weeks after end of neutropenia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner J Heinz, MD
Organizational Affiliation
University of Wuerzburg Medical Centre, Department of Internal Medicine II
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wuerzburg Medical Centre, Department of Internal Medicine II
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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