- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00056381
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
October 17, 2008 updated by: Pfizer
Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia
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).
Study Overview
Detailed Description
Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections.
Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
King of Prussia, Pennsylvania, United States, 19406
- Versicor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion (ACTUAL)
June 1, 2004
Study Registration Dates
First Submitted
March 11, 2003
First Submitted That Met QC Criteria
March 11, 2003
First Posted (ESTIMATE)
March 12, 2003
Study Record Updates
Last Update Posted (ESTIMATE)
October 21, 2008
Last Update Submitted That Met QC Criteria
October 17, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VER002-12
- A8851005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neutropenia
-
Hospira, now a wholly owned subsidiary of PfizerCompletedSolid Tumors | Malignant Hemopathy | Chemotherapy-induced Febrile Neutropenia (FN)France
-
TTY BiopharmCompletedNeutropenia, FebrileTaiwan
-
Institut RafaelActive, not recruitingPatient Satisfaction | Patient Preference | Febrile Neutropenia, Drug-InducedFrance
-
University of Mississippi Medical CenterUnknownPediatric Cancer | Chemotherapy-Induced Febrile Neutropenia | Chemotherapy-induced Neutropenia | Granulocyte Colony-Stimulating FactorUnited States
-
University Hospital, BrestCompletedNeutropenia, FebrileFrance
-
CinnagenCompletedChemotherapy-induced Neutropenia
-
University Hospital Inselspital, BerneCompletedFebrile Neutropenia | Pediatric Cancer | Oncology | Chemotherapy-induced NeutropeniaSwitzerland
-
University Hospital Inselspital, BerneCompletedFebrile Neutropenia | Pediatric Cancer | Oncology | Chemotherapy-induced NeutropeniaSwitzerland
-
BeyondSpring Pharmaceuticals Inc.CompletedChemotherapy-induced NeutropeniaChina, Russian Federation, United States, Ukraine
-
Jiangsu T-Mab Biopharma Co.,LtdCompletedChemotherapy-induced NeutropeniaChina
Clinical Trials on Anidulafungin
-
Radboud University Medical CenterCompletedLeukemia | Leukemia, Myeloid, Acute | Myelodysplastic SyndromeNetherlands
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Neutropenia | InfectionUnited States
-
PfizerCompletedCandidiasisUnited Kingdom
-
Daren K. HeylandPfizer; Queen's University; The Physicians' Services Incorporated FoundationTerminatedVentilator Associated Pneumonia | Respiratory Tract InfectionCanada
-
Radboud University Medical CenterCompletedObesity MorbidNetherlands
-
PfizerTerminatedCandidiasis | Fungemia | NeutropeniaPoland, Russian Federation, France, Bosnia and Herzegovina, Italy, Slovakia
-
PfizerVicuron PharmaceuticalsCompleted
-
PfizerVicuron PharmaceuticalsCompleted
-
PfizerVicuron PharmaceuticalsCompleted
-
PfizerTerminatedCandidiasis | FungemiaBelgium, United States, Canada, Switzerland, Netherlands, Bulgaria, Portugal, Romania, Russian Federation