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Anidulafungin in Patients With Hematologic Malignancies (ECALTA)

This study has been terminated.
(reduced recruitment rate due to non infectious, but competitive trials at our institution)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Michael Girschikofsky, Elisabethinen Hospital
ClinicalTrials.gov Identifier:
NCT01053884
First received: January 15, 2010
Last updated: March 1, 2012
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hematologic Malignancies
 Drug: Anidulafungin
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Elisabethinen Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Anidulafungin, safety, antifungal drug
single arm study
 Drug: Anidulafungin

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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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (≥ 18 years) with a hematologic disorder AND an indication for IFI prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic or renal dysfunction*, are scheduled to receive anidulafungin for one of the following specific indications:
  • Need for primary antifungal prophylaxis in patients with Acute leucaemia/MDS during induction, reinduction or consolidation chemotherapy (who are expected to become neutropenic for at least 10 days) OR after allogenic HSCT with GvHD (at least grade II or more - systemic steroid treatment required)
  • Need for secondary antifungal prophylaxis in patients with the history of a proven or probable invasive fungal infection who are expected to become neutropenic during induction, reinduction or consolidation chemotherapy

  • Indication for treatment of proven**, probable or possible fungal infection:

    • Neutropenic patients with fever resistant to antibiotics (empirical use)
    • Neutropenic patients with fever resistant to antibiotics and additive laboratory or imaging signs of IFI (preemptive use)
    • Patients who failed other antifungal therapy due to intolerance or progressive infection

Exclusion Criteria:

  • Absence of written informed consent
  • Female patients who are pregnant or lactating
  • Use of anidulafungin within 30 days prior to study
  • Known hypersensitivity to anidulafungin
  • Proven IFI with pathogen of known resistance to echinocandins (e.g. zygomycetes)
  • Life expectancy less than 1 month
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053884

Locations
Austria
Elisabethinen hospital
Linz, Upper Austria, Austria, 4020
Sponsors and Collaborators
Elisabethinen Hospital
Pfizer
Investigators
Study Chair: Michael Girschikofsky, MD Elisabethinen hospital Linz GmbH
  More Information

Publications:
De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Muñoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21.

Responsible Party: Michael Girschikofsky, OA Dr. Michael Girschikofsky, Elisabethinen Hospital
ClinicalTrials.gov Identifier: NCT01053884     History of Changes
Other Study ID Numbers: Anidulafungin - MG-ECALTA1, 2009-014527-23
Study First Received: January 15, 2010
Last Updated: March 1, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Elisabethinen Hospital:
Invasive Candidiasis
invasive fungal disease
Anidulafungin

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Anidulafungin
 Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013