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

Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients

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.

Study Overview

• Status: Completed
• Conditions: Fungal Infection
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caspofungin	Drug: caspofungin; Intermittent intravenous application of caspofungin; Other Names: Cancidas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 20 (average), till end of enutropenia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caspofungin pharmacokinetic	caspofungin serum concentrations	day 20 (average), at end of neutropenia
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.	day 100 after start of chemotherapy
Safety of intermittent caspofungin	Caspofungin related and all adverse and serious adverse events	day 34 (average), 2 weeks after end of neutropenia

Collaborators and Investigators

• Sponsor: Werner J. Heinz
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Chair: Werner J Heinz, MD, University of Wuerzburg Medical Centre, Department of Internal Medicine II

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 17, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Caspofungin; Prophylaxis; Aspergillosis; Antifungal; Echinocandins; Acute Leucemia
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: UKW-Inf-001; 2009-015159-26 (EudraCT Number)