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

Fungal Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318148
• Other study ID #: UKW-Inf-001
• Secondary ID: 2009-015159-26
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2011
• Last updated: January 8, 2014
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• caspofungin
Intermittent intravenous application of caspofungin

Locations

Country	Name	City	State
Germany	University of Wuerzburg Medical Centre, Department of Internal Medicine II	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
Werner J. Heinz	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Caspofungin pharmacokinetic	caspofungin serum concentrations	day 20 (average), at end of neutropenia	No
Secondary	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	No
Secondary	Safety of intermittent caspofungin	Caspofungin related and all adverse and serious adverse events	day 34 (average), 2 weeks after end of neutropenia	Yes