Anidulafungin in Patients With Hematologic Malignancies (ECALTA)
Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or treatment of invasive fungal infections (IFI) in hematologic patients.
Study design, Study conduct period Prospective, open label, phase II, one arm, single centre study October 2009 - September 2010
Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic and renal dysfunction respectively
Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes of important laboratory parameters with clinical impact will be reported.
Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized into success or failure. For patients receiving anidulafungin as prophylaxis the number and rate of breakthrough infections will be documented.
Risk assessment Treatment related adverse effects as reported in the approved physician prescribing information (usually mild and with an incidence of < 5%). Treatment failure due to resistant pathogens.
Expected benefit from this study IFI is a major cause of death among hematological patients, especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a new treatment option for patients in whom azoles or polyenes are relatively contraindicated.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Anidulafungin in Patients With Hematologic Malignancies - An Open-label, Prospective Study to Evaluate the Safety Profile at Prophylactic and Therapeutic Dosages|
- Safety: incidence of (serious)adverse events and changes of important laboratory parameters (in particular liver and renal function parameters) with clinical impact will be reported. [ Time Frame: day 1-5, 10 , end of treatment and study. ] [ Designated as safety issue: Yes ]
- pharmacokinetics and efficacy: As prophylaxis: the number of breakthrough infections. As treatment: complete and partial response rate (success); stable, progression and death (Failure) [ Time Frame: day 5 (pharmacokinetics), end of treatment, week 6 and 12 (efficacy) ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Anidulafungin, safety, antifungal drug
single arm study
standard dose: 200mg/d on day 1, followed by 100mg/d from day 2 as maintenance dose.
Prophylaxis will be given until the recovery from neutropenia (ANC > 1,0 G/L without myelosupportive medications) and in cases of active fungal infection until best response, in case of fungemia for at least 2 weeks after the first negative culture.
Other Name: Ecalta
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