NCT00056381

Brief Summary

Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

First QC Date

March 11, 2003

Last Update Submit

October 17, 2008

Conditions

Neutropenia

Keywords

neutropeniafeverfebrile neutropenia

Interventions

AnidulafunginDRUG

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Children ages 2-17 years with fever and neutropenia. * The expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Versicor

King of Prussia, Pennsylvania, 19406, United States

Location

MeSH Terms

Conditions

NeutropeniaFeverFebrile Neutropenia

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2003

First Posted

March 12, 2003

Study Start

July 1, 2003

Study Completion

June 1, 2004

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(1)