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

Phase 2

Completed

• Conditions: Fungal Infection
• Interventions: Drug: caspofungin

• Registration Number: NCT01318148
• Lead Sponsor: Werner J. Heinz

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.

Study Timeline

• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Study Start: 2011-04
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caspofungin	caspofungin	-

Primary Outcome Measures

Name	Time	Method
caspofungin pharmacokinetic	day 20 (average), till end of enutropenia	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.

Secondary Outcome Measures

Name	Time	Method
Caspofungin pharmacokinetic	day 20 (average), at end of neutropenia	caspofungin serum concentrations
Incidence of invasive fungal disease and outcome	day 100 after start of chemotherapy	Incidence of proven or probable invasive fungal disease according to the revised EORTC/MSG criteria during the period of prophylaxis and during follow up.
Safety of intermittent caspofungin	day 34 (average), 2 weeks after end of neutropenia	Caspofungin related and all adverse and serious adverse events

Trial Locations

Locations (1)

University of Wuerzburg Medical Centre, Department of Internal Medicine II; 🇩🇪 Wuerzburg, Germany