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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


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
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