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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fungal Infection

Intervention / Treatment
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* Drug: caspofungin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caspofungin<br> | Drug: caspofungin<br>* Intermittent intravenous application of caspofungin<br>* Other names: Cancidas;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echinocandins, Caspofungin, Pharmacokinetics, Prophylaxis, Antifungal, Aspergillosis, Acute Leucemia