Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease

NCT01249820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-12-08

No results posted yet for this study

Summary

The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.

Conditions

Interventions

DRUG

anidulafungin 200 mg q48h

Day 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages)

DRUG

anidulafungin 300 mg q72h

Day 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages)

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • R Brüggemann, PharmD · Radboud University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT01249820 on ClinicalTrials.gov