Clinical trial NCT01318148: Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fungal Infection
Keywords: Echinocandins
Caspofungin
Pharmacokinetics
Prophylaxis
Antifungal
Aspergillosis
Acute Leucemia
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-03-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: caspofungin pharmacokinetic
timeFrame: day 20 (average), till end of enutropenia
Secondary outcomes:
measure: Caspofungin pharmacokinetic
timeFrame: day 20 (average), at end of neutropenia
measure: Incidence of invasive fungal disease and outcome
timeFrame: day 100 after start of chemotherapy
measure: Safety of intermittent caspofungin
timeFrame: day 34 (average), 2 weeks after end of neutropenia
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg Medical Centre, Department of Internal Medicine II
Study officials:
affiliation: University of Wuerzburg Medical Centre, Department of Internal Medicine II
name: Werner J Heinz, MD
role: STUDY_CHAIR
References: