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Anidulafungin in Patients With Hematologic Malignancies

NCT01053884 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-03-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Elisabethinen Hospital

    lead OTHER

Principal Investigators

  • Michael Girschikofsky, MD · Elisabethinen hospital Linz GmbH

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Austria

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053884 on ClinicalTrials.gov